Label: LUCKY ITCH STOPPING- diphenhydramine hydrochloride zinc acetate cream

  • 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 December 20, 2020

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  • 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

  • INGREDIENTS AND APPEARANCE
    LUCKY  ITCH STOPPING
    diphenhydramine hydrochloride zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-168
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47046-168-0135.4 g in 1 TUBE; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2016
    Labeler - Anicare Pharmaceuticals Pvt. Ltd. (916837425)
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