Label: WELLY CALM BALM- anti itch cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 9, 2019

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  • 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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