Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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LUCKY ITCH STOPPING- diphenhydramine hydrochloride zinc acetate cream 
Delta Brands Inc

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 Ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

■  temporarily relieves pain and itching associated with ■ insect bites ■ minor burns ■ sunburn ■ minor skin irritations  ■ minor cuts ■ scrapes ■ rashes due to poison ivy, poison oak, and poison sumac ■ dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

For external use only

Do not use

■ on large areas of the body ■ with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use ■ on chicken pox ■ on measles

Ask a doctor before use

avoid contact with eyes

Stop use and ask a doctor if

■ condition worsens, or does not improve within 7 days ■ symptoms persist for more than 7 days or clear up and occur again wihin a few days

Keep out of reach of children

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

Directions

■ do not use more than directed 

■ adults and children2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

Other information

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, propylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Package Label

image description

LUCKY  ITCH STOPPING
diphenhydramine hydrochloride zinc acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 20276-325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 20276-325-3535.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/15/2014
Labeler - Delta Brands Inc (102672008)

Revised: 11/2014
 
Delta Brands Inc


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