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Mylo AirPrime Premium Diaper: Certified Hypoallergenic, Non-Irritant & Pediatrician Tested 

Diapering
Written by - Mylo BabyLast updated: Sep 16, 2026
Read time9 min

Mylo AirPrime Premium Diaper: Certified Hypoallergenic, Non-Irritant & Pediatrician Tested

When a diaper stays on your baby's skin for 10–12 hours a day, "gentle" can't just be a marketing word - it has to be proven. That's why Mylo AirPrime Premium Diaper wasn't put through one safety study, but two independent, ethics-committee-approved clinical studies at an ISO 9001 certified clinical research centre, Mascot Spincontrol India Pvt. Ltd., following the Bureau of Indian Standards protocol IS 4011:2018 (3rd Revision) - Methods of Test for Safety Evaluation of Cosmetics.

The results, verified and signed off by the testing laboratory:

  • Hypoallergenic: No allergic response observed in the challenge phase (HRIPT)

  • Non-Irritant: No irritative type response in either study

  • Clinically Tested

  • Dermatologically Tested

  • Pediatrician Tested

Two Studies. One Conclusion.

Most brands stop at a single patch test. Mylo AirPrime went further, with two separate certified evaluations:

Study 1: Human Repeat Insult Patch Test (HRIPT): The Hypoallergenic Standard

The HRIPT is the globally recognised gold-standard method for evaluating whether a product can trigger skin sensitization (allergy) with repeated use - exactly how a diaper is used in real life, day after day.

Under this Ethics Committee approved protocol (Study Code: D01-6Q11-MY-OR25), the diaper material was applied in occlusive patches 10 times over 40 days on 220 healthy human volunteers (110 males + 110 females), with every reaction graded by a dermatologist using the Draize scale during induction and the international ICDRG scale during the challenge phase.

Result (Certificate dated 25/02/2026):

  • No irritative type response during the induction phase

  • No allergic response during the challenge phase

  • Non-Irritant

  • Test product is Hypoallergenic

Study 2: Single Application Patch Test: Dermatologist + Paediatrician Supervised

In a second, separate study (Study Code: D01-6Q12-MY-OR25), the diaper underwent a Primary Irritation Patch Test under the direct supervision of both a Dermatologist and a Pediatrician, benchmarked against a positive control (1% SLS) and a negative control (0.9% isotonic saline) as per IS 4011:2018.

Result (Certificate dated 12/03/2026):

  • Mean irritation score: 0.0 (Draize scale, classification: Non-Irritant)

  • Clinically Tested

  • Dermatologically Tested

  • Pediatrician Tested

  • Non-Irritant

What Does This Mean for Your Baby?

In parent language:

  • "Hypoallergenic" here isn't a claim we wrote - it's a result the lab certified. After repeated exposure over 40 days, the diaper material produced no allergic sensitization under test conditions.

  • The skin-contact material scored zero on irritation. Both erythema (redness) and oedema (swelling) were assessed by a dermatologist under artificial daylight, against controls.

  • A pediatrician was in the room. The second study was conducted under dual medical supervision - dermatologist for skin reading, pediatrician for subject health monitoring.

Key Certificate Details

Detail

Study 1 (HRIPT)

Study 2 (Patch Test)

Product Tested

Mylo Baby Premium Diaper (Product A)

Mylo Baby Premium Diaper (Product A)

Test Method

Human Repeat Insult Patch Test (occlusive, repeated application)

Single Application Patch Test (occlusive)

Standard

IS 4011:2018, 3rd Revision (BIS)

IS 4011:2018, 3rd Revision (BIS)

Study Code

D01-6Q11-MY-OR25

D01-6Q12-MY-OR25

Volunteers

220 healthy adults (110 M + 110 F)

26 healthy volunteers

Duration

40 days (10 applications)

8 days incl. follow-up visit

Supervision

Dermatologist & Principal Investigator

Dermatologist & Pediatrician

Ethics Approval

ETHOS Institutional Ethics Committee

ETHOS Institutional Ethics Committee

CTRI Registration

CTRI/2025/11/097590

CTRI/2025/11/097591

Testing Lab

Mascot Spincontrol India Pvt. Ltd. (ISO 9001, Bureau Veritas certified)

Mascot Spincontrol India Pvt. Ltd.

Certificate Date

25/02/2026

12/03/2026

Signed By

Mrs. Mumtaz Lalvani, Chief Executive Officer

Mrs. Mumtaz Lalvani, Chief Executive Officer

Result

Non-Irritant, Hypoallergenic

Non-Irritant; Clinically, Dermatologically & Pediatrician Tested

The Product: Mylo AirPrime Premium Diaper Pants

The certified skin-safety layer sits inside a diaper built around one idea: babies grow better when they move better.

  • Ultra-thin, lightweight design with high absorbency: Up to 12 hours of dryness without the bulk

  • Bubble Top Sheet: Airy, cushiony layer that reduces direct wetness contact

  • 10 million+ breathable micro pores: Air circulates, heat and dampness don't build up

  • Anti-rash comfort with Aloe Vera + Shea Butter

  • Cloud Touch Belt: Soft, stretchable waistband that doesn't dig in or leave marks

  • Triple Leak Guard: Side and back leak protection through active play and long nights

  • Smart Wetness Indicator: Yellow turns blue when it's time to change

  • Organic dyes, no harsh chemicals

Available in sizes S through XXL (5–25 kg).

Shop Mylo AirPrime Premium Diapers

Why Trust This Certification?

  1. Independent lab, not in-house testing. Both studies were conducted by Mascot Spincontrol India Pvt. Ltd., an ISO 9001 (Bureau Veritas) certified clinical research centre operating under ICH-E6 Good Clinical Practice.

  1. Registered before recruitment. Both studies were registered with the Clinical Trials Registry of India (CTRI) after Ethics Committee approval — subject recruitment began only after registration.

  1. Controls, not just observations. Study 2 used positive (1% SLS) and negative (saline) controls; the positive control produced the expected irritation score (2.1) while the diaper scored 0.0, validating the test itself.

  1. Conducted per the Declaration of Helsinki (75th WMA, October 2024) and audited at every stage by the lab's quality assurance department.

Embed: HRIPT certificate - "Tested by Mascot Spincontrol" - dated 25/02/2026

Embed: Patch Test certificate - dated 12/03/2026

Certificate Transcriptions

Certificate 1 (25/02/2026):

Mylo Baby Premium Diaper was evaluated upon Ethics Committee approved protocol for Human Repeat Insult Patch Test (HRIPT) on healthy human volunteers:

  • No irritative type response during induction phase

  • No allergic response during challenge phase

  • Non-irritant

  • Test product is Hypoallergenic

- Mrs. Mumtaz Lalvani, Chief Executive Officer, Mascot Spincontrol Clinical Research Centres

Certificate 2 (12/03/2026):

Mylo Baby Premium Diaper was evaluated upon Ethics Committee approved protocol on healthy minor volunteers and is:

  • Clinically tested

  • Dermatologically tested

  • Pediatrician tested

  • Non-irritant

- Mrs. Mumtaz Lalvani, Chief Executive Officer, Mascot Spincontrol Clinical Research Centres

FAQs

1. What does "Hypoallergenic" mean on the certificate?

It means that in the Human Repeat Insult Patch Test, repeated applications over 40 days on 220 volunteers - no allergic sensitization response was observed by the supervising dermatologist. It reflects the certified test outcome, not a guarantee that no baby can ever react; every child's skin is unique.

2. What is an HRIPT and why does it matter for diapers?

The Human Repeat Insult Patch Test checks whether repeated skin contact causes sensitization (allergy) over time. Since diapers are worn daily for months, repeated-exposure testing is far more relevant than a one-time check.

3. What does "Non-Irritant" mean?

Under IS 4011:2018, a mean Draize score up to 2.0/8.0 classifies a product as Non-Irritant. Mylo AirPrime's material scored 0.0 - no erythema, no oedema in both studies.

4. Who supervised the testing?

Study 1 was conducted under a Dermatologist as Principal Investigator. Study 2 was conducted under both a Dermatologist and a Pediatrician.

5. Was the actual diaper material tested?

Yes. The diaper material was cut to size and applied in aluminium Finn Chambers directly on skin under occlusion - a more demanding exposure than normal wear.

6. Were the studies independently registered?

Yes. Both studies received ETHOS Institutional Ethics Committee approval and were registered with the Clinical Trials Registry of India (CTRI/2025/11/097590 and CTRI/2025/11/097591) before recruitment began.

7. Is Mylo AirPrime safe for newborn or sensitive skin?

The diaper is certified Non-Irritant and Hypoallergenic under test conditions, and its skin-contact layer includes aloe vera and shea butter. For babies with existing skin conditions, always follow your pediatrician's advice.

8. Where can I see the certificates?

Both original certificates are displayed on this page, issued and signed by Mascot Spincontrol India Pvt. Ltd.

The Bottom Line

Most diapers ask for your trust. Mylo AirPrime shows its proof - two ethics-approved clinical studies, 246 total volunteers, dermatologist and pediatrician supervision, and certified results of Non-Irritant and Hypoallergenic. Ultra-thin comfort your baby feels, verified safety you can read.

Buy Mylo AirPrime Premium Diapers now

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Shop Mylo Premium Diapers for Baby

Mylo Airprime™ Premium Diaper Pants with Wetness Indicator - S(5-9 Kgs) - 52 Count

Mylo Airprime™ Premium Diaper Pants with Wetness Indicator - S(5-9 Kgs) - 52 Count

Rash-free | Leak-proof | Ultra-thin | Breathable | Wetness Indicator | Bubble Top Sheet | Pediatrician Tested Diaper | Expert Approved | No Harsh Bleaching Chemicals

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice. Consult with a physician or other health care professional if you have any concerns or questions about your health. If you rely on the information provided here, you do so solely at your own risk.

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