VITACILINA BEBE DIAPER RASH- zinc oxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Taisho Pharmaceutical California Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps treat and prevent diaper rash  - protect chafed skin due to diaper rash and helps seal out wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

VITACILINA BEBE DIAPER RASH- ZINC OXIDE OINTMENT
TAISHO PHARMACEUTICAL CALIFORNIA INC.
----------
VITACILINA BEBE DIAPER RASH OINTMENT
_DRUG FACTS_
_ACTIVE INGREDIENT_
Zinc Oxide 40%
_PURPOSE_
Skin Protectant
_USES_
helps treat and prevent diaper rash
protect chafed skin due to diaper rash and helps seal out wetness
_WARNINGS_
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES.
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last more than 7 days or 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: 800-222-
1222.
_DIRECTIONS_
change wet and soiled diapers promptly
cleanse the diaper area
allow to dry
apply ointment liberally as often as necessary, with each diaper
change, especially at
bedtime or any time when exposure to wet diapers may be prolonged
_OTHER INFORMATION_
store at 15 to 30°C (59 to 86°F)
DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING. TAMPER EVIDENT:
_INACTIVE INGREDIENTS_
paccohol, coconut butter, corn starch, fragrance,
hydroxyethylcellulose, lanolin,
methylparaben, mineral oil, petrolatum, polysorbate 20, purified
water, shea butter
PACKAGE LABELING:
VITACILINA BEBE DIAPER RASH
zinc oxide ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81929-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
400 mg in 1 g
Taisho Pharmaceutical California Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CETYL ALCOHOL (UNII: 936JST6JCN)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
PACKAGING
#
ITEM CODE
PACKAGE DESC