FAMILY CARE ANTI-ITCH  - diphenhydramine hydrochloride cream 
TAI GUK PHARM. CO., LTD.

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.

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DRUG FACTS


Active Ingredients                                                                                  Purpose

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

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

Uses

For external use only

Do not use

When using this product avoid contact with the eyes

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.  If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients

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

Distributed by:

Consumer Care Products Corp.

Cerritos, CA 90703   USA

image of carton labelEnter section text here

FAMILY CARE ANTI-ITCH  
diphenhydramine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE10 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68169-0049-51 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/16/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)

Revised: 4/2010
Document Id: b99dff4c-9cf4-45f8-ab70-4d5450b85235
Set id: f3718c8f-51e6-4aad-b4b2-a9f65e1dbf4a
Version: 12
Effective Time: 20100416
 
TAI GUK PHARM. CO., LTD.