Label: ASPERCREME WARMING- capsaicin patch

  • 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 2, 2019

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

  • SPL UNCLASSIFIED SECTION

    ASPERCREME WARMING PAIN RELIEF PATCH

    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)

    ■ 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

    ■ dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

    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:

    ■ clean and dry affected area

    ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

    ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

    ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area

    ■ apply one patch to affected area for up to 8 hours, repeat as necessary, but no more than 3 times a day

    AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    children under 18 years of age: ask a doctor

  • Inactive ingredients

    aluminum hydroxide, benzyl alcohol, cellulose gum, disodium EDTA, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, tocopherol, water

    Keep carton as it contains important information.

  • PRINCIPAL DISPLAY PANEL

    Aspercreme
    WARMING
    PAIN RELIEF PATCH
    Contains 5 patches in 1 resealable pouch
    0.025% Capsaicin

    PRINCIPAL DISPLAY PANEL
Aspercreme
WARMING
PAIN RELIEF PATCH
Contains 5 patches in 1 resealable pouch 
0.025% Capsaicin

  • INGREDIENTS AND APPEARANCE
    ASPERCREME WARMING 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1920
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1.506 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-1920-11 in 1 CARTON01/02/2019
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/02/2019
    Labeler - Chattem, Inc. (003336013)