Label: ASPERCREME WARMING NO MESS- capsaicin gel

  • 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 March 5, 2019

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

  • SPL UNCLASSIFIED SECTION

    ASPERCREME WARMING GEL

    Drug Facts

  • Active ingredient

    Capsaicin 0.025%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises ■ cramps

  • Warnings

    For external use only

    When using this product

     read inside of carton before using

     use only as directed. Read and follow all directions and warnings on this carton.

    ■ avoid contact with the eyes and mucous membranes

     rare cases of serious burns have been reported with products of this type

    ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

    ■ do not apply to wounds or damaged, broken or irritated skin

    ■ do not use at the same time as other topical analgesics

    ■ discontinue use at least 1 hour before a bath or shower

    ■ a transient burning sensation may occur upon application but generally disappears in several days

    ■ if severe burning occurs, discontinue use immediately and read inside carton for important information

    ■ do not expose the area treated with product to heat or direct sunlight

    ■ avoid applying into skin folds

    Stop use and ask a doctor if

     condition worsens

    ■ redness is present

    ■ irritation develops

    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children and pets.

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

  • Directions 

    adults 18 years of age and older:

    ■ apply a thin layer to affected area

    ■ using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed

    ■ repeat if necessary, but no more than 3 to 4 times daily

    AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    children under 18 years of age: ask a doctor

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, citric acid, disodium EDTA, ethylhexylglycerin, glycerin, methylparaben, propylene glycol, steareth-2, steareth-21, triethanolamine, water

    Keep carton as it contains important information.

  • PRINCIPAL DISPLAY PANEL

    Aspercreme
    WARMING
    PAIN RELIEVING GEL
    NO MESS GEL
    APPLICATOR
    Net wt 2.5 oz (70.8 g)

    Aspercreme
WARMING
PAIN RELIEVING GEL
NO MESS GEL
APPLICATOR
Net wt 2.5 oz (70.8 g)

  • INGREDIENTS AND APPEARANCE
    ASPERCREME WARMING NO MESS 
    capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1922
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.00025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1922-01 in 1 CARTON03/05/2019
    170.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/05/2019
    Labeler - Chattem, Inc. (003336013)