Drug Facts

Active ingredients

Allantoin 1% Zinc Oxide 25%

Purpose

Skin Protectant

Uses

• Treats and prevents diaper rash

• Protects minor skin irritation associated with diaper rash

• Helps seal out wetness

Warnings

For external use only
Avoid contact with the eyes
If condition worsens or does not improve within 7 days, consult a doctor

Keep out of the reach of children

Directions

Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry. Apply ointment as often as necesary with each diaper change, especially at bedtime or anytime when exposure to wet diapers maybe prolonged.

Inactive Ingredients

Petrolatum, corn starch, fragrance, lanolin, methylparaben, mineral oil, propylparaben, vitamin A (palmitate), vitamin D (calciferol), vitamin E (tocopherol).

Package Labeling:

Outer Package5 Outer Package6 Inner Package5

VITACILINA BEBE DIAPER RASH
allantoin, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54312-525
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	10 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	250 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
STARCH, CORN (UNII: O8232NY3SJ)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54312-525-16	1 in 1 PACKAGE	09/30/2013
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	09/30/2013

Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (822165213)

VITACILINA Bebe Diaper Rash Ointment