FDA.reportPublic FDA data

diaper rash cream

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2020-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:39

Label at a glance#

ProductMy Fair Baby Diaper Rash
Active ingredientZINC OXIDE
Label structure11 sections

Dosage and administration

Change wet and soiled diapers promptly Cleanse the diaper area Allow to dry Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13%

Purpose

OTC - PURPOSE SECTION

Skin Protection

Use

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Soothes and relieves irritated skin
  • Protects your baby's skin from wetness

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens or does not improve within 7 days or symptoms clear up and occur again within a few days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area
  • Allow to dry
  • Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

SPL UNCLASSIFIED SECTION

Store at 20º to 25°C (68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Mineral Oil, Petrolatum, Cetyl Alcohol, Ceteareth-25, Glyceryl Monostearate, Beeswax, Microcrystaline Wax, Fragrance, Dimethicone, Aloe Barbadensis Leaf Extract (Aloe Vera), Tocopheryl Acetate, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Carbomer

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
349404zinc oxide 13 % Topical CreamPSN1
349404zinc oxide 130 MG/ML Topical CreamSCD1
349404zinc oxide 13 % Topical CreamSY1
349404ZNO 130 MG/ML Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-179-022022-01-28C16284748780-1d6a99b39-b4e5-a426-e053-dadaa90af4c2diaper rash cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-179-01My Fair BabyDiaper Rash28 g in 1 TUBECREAM281
47046-179-02My Fair BabyDiaper Rash1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-179MY FAIR BABY DIAPER RASH (ZINC OXIDE) CREAM [ANICARE PHARMACEUTICALS PVT. LTD.]1Legacy NDC, 2 package rows20201221_b6e209c8-09be-eac2-e053-2a95a90a4751.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-17947046-179-01, 47046-179-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
CETYL ALCOHOL936JST6JCNIACT
CETEARETH-258FA93U5T67IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
WHITE WAX7G1J5DA97FIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6e209d2-ad7c-e39e-e053-2a95a90aec68b6e209c8-09be-eac2-e053-2a95a90a47512020-12-20WarningsExact identifier
spl id: b6e209d2-ad7c-e39e-e053-2a95a90aec68
spl set id: b6e209c8-09be-eac2-e053-2a95a90a4751

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.