Label: FAMILY CARE ANTI-ITCH- diphenhydramine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68169-0049-5 - Packager: TAI GUK PHARM. CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 16, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
- children under 12 years of age, consult a doctor
- do not use with any other product containing diphenhydramine, even one taken by mouth
- discontinue use and consult a physician if rash or irritation develops
- SAFE HANDLING WARNING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY CARE ANTI-ITCH
diphenhydramine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68169-0049 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 10 mg in 1 g ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68169-0049-5 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/16/2010 Labeler - TAI GUK PHARM. CO., LTD. (631101656)