Label: FAMILY WELLNESS- diphenhydramine hydrochloride, zinc acetate cream

  • NDC Code(s): 69571-005-01, 69571-005-02
  • Packager: FRONT PHARMACEUTICAL PLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Diphenhydramine hydrochloride 2%

    Zinc acetate 0.1%

  • PURPOSE

    Purpose

    Topical analgesic

    Skin protectant

  • INDICATIONS & USAGE

    for temprary relief from pain and itching associated Uses

    with insect bites , sunburn and mior skin irritations. Dries the

    oozing and weeping of poison: •ivy  •oak  •sumac

  • WARNINGS

    Warnings

    . For external use only

    Do not use

    •avoid contact with eyes When using this product

    Ask a doctor before use

    •on chicken pox  •on measles

    Stop use and ask a doctor if

    • over large areas of the body
    • with any other product containing diphenhydramine including those taken orally
    • symptoms last for more than 7 days
    • the condition gets worse
    • symptoms clear up and then occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    . If swallowed, get medical help Keep out of reach of children

    or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    •for adults and children over 2 years of age: apply to affected

    area not more than 3 to 4 times daily

    •children under 2 years of age: ask a doctor before use

  • OTHER SAFETY INFORMATION

    store at room temperature 59° - 86° F Other information

    (15° - 30° C).

  • INACTIVE INGREDIENT

    cetyl alcohol, glyceryl stearate se, Inactive ingredients

    laureth-23, methylparaben, mineral oil, petrolatum, propylene

    glycol, propylparaben, stearic acid, stearic alcohol, water

  • QUESTIONS

    1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

  • label

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-005
    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)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-005-021 in 1 BOX03/29/2017
    1NDC:69571-005-0128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/29/2017
    Labeler - FRONT PHARMACEUTICAL PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    FRONT PHARMACEUTICAL PLC530897792manufacture(69571-005)
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