VITACILINA BEBE DIAPER RASH- allantoin, zinc oxide ointment

VITACILINA Bebe Diaper Rash by

Drug Labeling and Warnings

VITACILINA Bebe Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Compania Internacional de Comercio, S.A.P.I de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Allantoin 1%
Zinc Oxide 25%

Purpose

Skin Protectant

Uses

Treats & 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, vitamin D (calciferol)

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/30/2013

Labeler - Compania Internacional de Comercio, S.A.P.I de C.V. (815039995)

Establishment
Name	Address	ID/FEI	Business Operations
Farmaqro, S.A. de C.V.		588161468	manufacture(54312-525)