VITACILINA BEBE DIAPER RASH- allantoin, zinc oxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Allantoin 1% Zinc Oxide 25%, Skin Protectant

Available from:

Compania Internacional de Comercio, S.A.P.I de C.V.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

• Treats and prevents diaper rash • Protects minor skin irritation associated with diaper rash • Helps seal out wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

VITACILINA BEBE DIAPER RASH- ALLANTOIN, ZINC OXIDE OINTMENT
COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.
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VITACILINA BEBE DIAPER RASH OINTMENT
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:
Compania Internacional de Comercio, S.A.P.I de C.V.
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 CATION - UNII:13S1S8SF37)
ZINC CATION
250 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
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)
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
DAT