Aquaphor Healing Diaper Rash Cream

SPL v11

SPL

SPL Set ID dec07dfc-67a2-46ad-8fab-828488bdba15

Route

TOPICAL

Published

Effective Date 2020-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (15 g)

Inactive Ingredients

Mineral Oil Ceresin Glycerin Panthenol Magnesium Stearate Water Polyglyceryl-4 Isostearate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-01-30

Description

Zinc Oxide 15%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses

• helps treat and prevent diaper rash

• protects chafed skin associated with diaper rash and helps protect from wetness

Description

Zinc Oxide 15%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if • condition worsens

• symptoms last more than 7 days or clear up and occur

again within a few days

Section 50567-7

When using this product • avoid contact with eyes

Section 51727-6

Inactive Ingredients

Mineral Oil, Glycerin, Ceresin, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate,

Magnesium Stearate, Panthenol, Water

Section 51945-4

Aquaphor Healing Cream

Baby

3 in 1

Diaper Rash Cream

Prevents Soothes Treats

Hypoallergenic

Cleans Off Easily

Paraben and Fragrance Free

15% Zinc Oxide Skin Protectant

Pediatrician Recommended Brand

Section 53413-1

Questions or comments

1-800-227-4703

Section 55105-1

Skin Protectant

Section 55106-9

Zinc Oxide 15%

Structured Label Content

Indications and Usage (34067-9)

Uses

• helps treat and prevent diaper rash

• protects chafed skin associated with diaper rash and helps protect from wetness

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if • condition worsens

• symptoms last more than 7 days or clear up and occur

again within a few days

Section 50567-7 (50567-7)

When using this product • avoid contact with eyes

Section 51727-6 (51727-6)

Inactive Ingredients

Mineral Oil, Glycerin, Ceresin, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate,

Magnesium Stearate, Panthenol, Water

Section 51945-4 (51945-4)

Aquaphor Healing Cream

Baby

3 in 1

Diaper Rash Cream

Prevents Soothes Treats

Hypoallergenic

Cleans Off Easily

Paraben and Fragrance Free

15% Zinc Oxide Skin Protectant

Pediatrician Recommended Brand

Section 53413-1 (53413-1)

Questions or comments

1-800-227-4703

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Zinc Oxide 15%

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYGLYCERYL-4 ISOSTEARATE", "unii": "820DPX33S7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • helps treat and prevent diaper rash • protects chafed skin associated with diaper rash and helps protect from wetness", "34071-1": "For external use only", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days", "50567-7": "When using this product • avoid contact with eyes", "51727-6": "Inactive Ingredients Mineral Oil, Glycerin, Ceresin, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Magnesium Stearate, Panthenol, Water", "51945-4": "Aquaphor Healing Cream Baby 3 in 1 Diaper Rash Cream Prevents Soothes Treats Hypoallergenic Cleans Off Easily Paraben and Fragrance Free 15% Zinc Oxide Skin Protectant Pediatrician Recommended Brand", "53413-1": "Questions or comments 1-800-227-4703", "55105-1": "Skin Protectant", "55106-9": "Zinc Oxide 15%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:42.414451 · Updated: 2026-03-14T23:11:26.161918