FAMILY CARE ANTI-ITCH- diphenhydramine hydrochloride cream

FAMILY CARE ANTI-ITCH by

Drug Labeling and Warnings

FAMILY CARE ANTI-ITCH by is a Otc medication manufactured, distributed, or labeled by TAI GUK PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                                                  Purpose

Diphenhydramine Hydrochloride USP, 1%................................................Antihistamine

Zinc acetate, 0.1%.................................................................................Skin Protectant

PURPOSE

Uses

• for the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, poison sumac
• dries the oozing and weeping of poison ivy, poison oak and poison sumac
  

WARNINGS

For external use only

DO NOT USE

Do not use

• on chicken pox, measles, blisters or on extensive areas of the skin
• any other drug containing diphenhydramine while using this product
  

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

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

Other information

• store at room temperature
• Lot No. and Exp. Date: see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive ingredients

Propylene Glycol, Cetanol, Polyoxyl 40 Stearate, Stearyl Alcohol, Methylparaben, Propylparaben, Purified Water

DOSAGE & ADMINISTRATION

Distributed by:

Consumer Care Products Corp.

Cerritos, CA 90703   USA

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

FAMILY CARE ANTI-ITCH  
diphenhydramine hydrochloride cream

Product 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)