Label: ASPERCREME PAIN RELIEVING- trolamine salicylate cream

  • NDC Code(s): 41167-0570-1, 41167-0570-3, 41167-0570-4, 41167-0570-5, view more
    41167-0570-6
  • Packager: Chattem, Inc.
  • 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 November 19, 2021

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  • SPL UNCLASSIFIED SECTION

    ASPERCEME® Pain Relieving Creme

    Drug Facts

  • Active ingredient

    Trolamine salicylate 10%

  • Purpose

    Topical analgesic

  • Uses

    temporary relieves minor pain associated with: 

    • arthritis
    • simple backache  
    • muscle strains
    • sprains
    • bruises
    • cramps
  • Warnings

    For external use only

    Allergy alert:

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    • use only as directed. Read and follow all directions and warnings on this label.
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged, broken or irritated skin
    • do not use at the same time as other topical analgesics

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    adults and children over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 3 to 4 times daily

    children 12 years and younger: ask a doctor

  • Inactive ingredients

    aloe barbadensis leaf juice, cetyl alcohol, glycerin, methylparaban, mineral oil, potassium phosphate, propylparaban, stearic acid, triethanolamine, water

    Close cap tightly after use.

  • PRINCIPAL DISPLAY PANEL

    MAX STRENGTH
    Aspercreme®
    ORIGINAL
    with 10% Trolamine Salicylate
    PAIN RELIEF CREAM
    NET WT 3 oz (85 g)

    MAX STRENGTH
Aspercreme®
ORIGINAL 
with 10% Trolamine Salicylate
PAIN RELIEF CREAM
NET WT 3 oz (85 g)

  • INGREDIENTS AND APPEARANCE
    ASPERCREME PAIN RELIEVING 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0570
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0570-11 in 1 CARTON12/01/1998
    135 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-0570-31 in 1 CARTON12/01/1998
    285 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-0570-41 in 1 CARTON12/01/1998
    3106 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:41167-0570-51 in 1 CARTON12/01/1998
    4142 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:41167-0570-6177 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/199812/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/1998
    Labeler - Chattem, Inc. (003336013)