MY FAIR BABY DIAPER RASH- zinc oxide cream

My Fair Baby by

Drug Labeling and Warnings

My Fair Baby by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 13%

Purpose

Skin Protection

Use

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

Warnings

For external use only

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

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

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

Directions

• 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

Store at 20º to 25°C (68° to 77°F)

Inactive Ingredients

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

INGREDIENTS AND APPEARANCE

MY FAIR BABY  DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARETH-25 (UNII: 8FA93U5T67)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WHITE WAX (UNII: 7G1J5DA97F)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-321-01	1 in 1 CARTON	08/30/2011
1	NDC: 20276-321-10	28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 20276-321-02	1 in 1 CARTON	08/30/2011
2	NDC: 20276-321-15	43 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 20276-321-03	1 in 1 CARTON	08/30/2011
3	NDC: 20276-321-20	57 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 20276-321-04	1 in 1 CARTON	08/30/2011
4	NDC: 20276-321-25	70 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 20276-321-05	1 in 1 CARTON	08/30/2011
5	NDC: 20276-321-30	84 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 20276-321-06	1 in 1 CARTON	02/01/2019
6	NDC: 20276-321-45	127 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/30/2011

Labeler - Delta Brands Inc (102672008)