Label: CVS HEALTH FIRST AID OUTDOOR PREP-PACK- ammonia kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 20, 2017

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  • Active Ingredient

    Active Ingredient:

    Ammonia 3.5%

  • Purpose

    Counterirritant

  • Use

    Temporarily protects and helps relieve minor skin irriatation and itching due to

    • insect bites and stings
    • poison ivy, oak or sumac
  • Warnings

    Warning:   For external use only.

  • 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.

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • When using this product

    Do not get into eyes

  • Directions

    Adults and children under 2 years and older dab directly on bite or sting, rub gently and re-apply as needed

    Children under 2 years ask a doctor


  • Inactive Ingredients

    Alcohol Ethoxylate, Dimethicone, Mineral Oil and Purified Water


  • PRINCIPAL DISPLAY PANEL

    After Bite

    The Itch Eraser

    Fast Relief from Insect Bites.

    Net Contents: 0.037fl. oz.

    Contains: One (1) Wipe

    Contains Ammonia

    Tender Corporation

    Littleton, NH 03561

    After Bite WipeOutdoor Prep Pack

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH FIRST AID OUTDOOR PREP-PACK 
    ammonia kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-407
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-407-001 in 1 KIT; Type 0: Not a Combination Product12/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PACKAGE 3 mL
    Part 1 of 1
    AFTER BITE WIPE 
    ammonia swab
    Product Information
    Item Code (Source)NDC:44224-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    C12-13 ALCOHOLS (UNII: T7ZJT3I9X2)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-0001-20.7 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2014
    Labeler - CVS (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(69842-407)
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