Label: FAMILY WELLNESS- diphenhydramine hydrochloride, zinc acetate cream

  • NDC Code(s): 55621-007-01
  • Packager: Zhejiang Jingwei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • INACTIVE INGREDIENT

    Inactive Ingredients - cetyl alcohol, glycerol stearate,

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

    glycol, propylparaben, stearic acid, stearyl alcohol, water

  • ACTIVE INGREDIENT

    Active Ingredients

    Diphenhydramine hydrochloride 2 %

    Zinc acetate 0.1 %

  • PURPOSE

    Purpose

    ---Topical analgesic

    ---Skin protectant

  • INDICATIONS & USAGE

    Uses  for temporary relief from pain and itching associated

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

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

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    -over large areas of the body

    -with any other product containing diphenhydramine,

    including those taken orally

  • WHEN USING

    When using this product - avoid contact with eyes

  • ASK DOCTOR

    Ask a doctor before use

    -on chicken pox

    -on measles

  • STOP USE

    Stop use and ask a doctor if:

    -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

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

    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 or 4 times per day

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

  • STORAGE AND HANDLING

    Other information - store at room temperature 59 - 86 F (15 - 30 C)

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-007
    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 MONOSTEARATE (UNII: 230OU9XXE4)  
    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:55621-007-011 in 1 BOX11/01/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2013
    Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
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