WELLY CALM BALM (ANTI ITCH CREAM) CREAM [WELLY HEALTH PBC]

WELLY CALM BALM (ANTI ITCH CREAM) CREAM [WELLY HEALTH PBC]
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NDC 72663-069-50
Set ID ac4c2623-6a84-4908-b018-956bb978aa56
Category HUMAN OTC DRUG LABEL
Packager Welly Health PBC
Generic Name
Product Class
Product Number
Application Number PART347
  • Drug Facts:

  • Active ingredients

    Diphenhydramine hydrochloride 2%

    Zinc Acetate 0.1%

  • Purpose

    Topical analgesic

    Skin protectant

  • Uses

    For temporary relief from pain and itching associated with :

    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • rashes due to poison ivy, poison oak, and poison sumac

    Dries the oozing and weeping of poison

    • ivy
    • oak
    • 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 the mouth.

    Ask a Doctor before use

    • on chicken pox
    • on measles

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if

    • conditions worsen or does not improve within 7 days
    • symptoms persist for more than 7 days or clear up and occur agian within a few days

  • Keep this and all drugs out of the reach of children.

    If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    • do not use more than directed
    • adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
    • children under 2 years of age , consult a doctor

    Other Information

    • Store at controlled room temperature 20°-25°C (68° - 77°F)
    • Close the cap tightly after use
  • Inactive ingredients

    Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceryl Sterate, Methylparaben, Polyethylene Glycol Monosterate  1000, Propylene Glycol, Propylparaben, Sodium Citrate , Purified Water

  • Principal Display Panel .57 oz  Tube

     Welly First aid    NDC 72663-069-59

    Extra Strength ANTI -ITCH cream

    2% Diphenhydramine HCL topical analgesic

    0.1% Zinc Acetate skin protectant

    NET WT 0.57 oz (16g)

    Principal Display Panel .57 oz  Tube

    Principal Display Panel .57 oz  Tube

  • Principal Display Panel -Can 

    Welly Calm Balm First aid NDC 72663-069-59


    Extra Strength ANTI -ITCH cream


    2% Diphenhydramine HCL topical analgesic

    0.1% Zinc Acetate skin protectant

    NET WT 0.57 oz (16g) 

    2- Tubes  1.14 oz ( 32g)

    Principal Display Panel -Can

    Principal Display Panel -Can

  • INGREDIENTS AND APPEARANCE
    WELLY CALM BALM 
    anti itch cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-069-502 in 1 CAN02/09/2019
    116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/09/2019
    Labeler - Welly Health PBC (116766884)
    Registrant - Welly Health PBC (116766884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(72663-069)

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