Label: AWAYE- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL

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 28, 2022

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  • Active ingredient                                   Purpose

    Capsaicin 0.025%                                 Topical analgesic

  • PURPOSE

  • Uses

    Temporarily relieves aches and pains of muscles and joints associated with: simple backache – lumbago – strains – sprains - arthritis

  • Warning

    For external use only
    Flammable: Keep away from fire or flame and heated surfaces.
    Do not use – if you are allergic to any ingredient in this product - on open wounds, damaged, broken or irritated skin - with external heat, such as an electric heating pad or a TENS device.
    When using this product – Use only as directed - Avoid contact with the eyes or mucus membranes - Do not tightly bandage - Do not inhale.
    Stop use and ask a doctor if – condition worsens – headache, rash, itching, erythema, redness, burning discomfort or excessive irritation of the skin develops - symptoms persist for more than 7 days – symptoms clear up and occur again within a few days.
    If pregnant or breastfeeding, ask a healthcare professional before use.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

  • Direction

    Apply 2 pumps to affected area no more than 3-4 times a day - Rub in well until absorbed by the skin - wash hands thoroughly after use with cold water - May take up to 2 weeks for a greater effect.

  • Inactive ingredient

    B-Caryophyllene, Benzyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, C13-14 Isoparaffin, Laureth-7, Oleic Acid, PEG100 Stearate, Polyacrylamide, Polysorbate 80, Potassium Sorbate, Purified Water, Xantham Gum.

  • Other information

    Store in a cool dry place away from direct sunlight – Store with cap closed tightly – Do not use if seal is broken.

  • Product label

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  • INGREDIENTS AND APPEARANCE
    AWAYE 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82531-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82531-001-0145 g in 1 BOTTLE; Type 0: Not a Combination Product03/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/07/2022
    Labeler - Lumiera Health Inc. (208214151)