Label: BITE AND ITCH - diphenhydramine hydrochloride and pramoxine hydrochloride lotion 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/11

If you are a consumer or patient please visit this version.

  • Active ingredients


    Diphenhydramine HCl 2%

    Pramoxine HCl 1%

    Purpose

    Topical Analgesic

    Topical Analgesic

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  • Uses

    temporarily relieves pain and itching due to:

    • scrapes
    • minor burns
    • poison ivy, poison oak, or poison sumac
    • sunburn
    • insect bites
    • minor cuts
    • minor skin irritations
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  • 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 if you have

    • chicken pox
    • measles

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition gets worse
    • symptoms last for more than 7 days clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • do not use more often than directed
    • adults and children 12 years and over: apply to affected areanot more than 3 to 4 times daily
    • children under 12 years: ask a doctor
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  • Other information

    • store at controlled room temperature
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  • Inactive ingredients

    cetyl alcohol, glyceryl monostearate, isopropyl myristate, menthol, mineral oil, polysorbate 60, propylene glycol, purified water, sodium benzoate, stearyl alcohol

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  • Bite and Itch Lotion 4 oz Labeling


    Bite and Itch 4 oz Lotion

    This product is also labeled as Solarhist Lotion. All other labeling and packaging is the same.

    Labeled and Dist. by:

    Weeks and Leo Co. Inc.

    Des Moines, IA 50322

    Bite and Itch Lotion 4oz

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  • INGREDIENTS AND APPEARANCE
    BITE AND ITCH 
    diphenhydramine hcl and pramoxine hcl lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11383-193
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 20 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    ISOPROPYL MYRISTATE  
    MENTHOL  
    MINERAL OIL  
    POLYSORBATE 60  
    PROPYLENE GLYCOL  
    SODIUM BENZOATE  
    STEARYL ALCOHOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11383-193-04 113 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/06/2000
    Labeler - Weeks & Leo Co., Inc. (005290028)
    Registrant - DSC Laboratories, Div. of DSC Products Inc. (097807374)
    Establishment
    Name Address ID/FEI Business Operations
    DSC Laboratories, Div. of DSC Products Inc. 097807374 manufacture
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