ASPERCREME HEAT- menthol gel 
Chattem, Inc.

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.

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Aspercreme Heat

Aspercreme Heat Pain Relieving Gel

Drug Facts

Active ingredient

Menthol 10%

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

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • a transient burning sensation or redness may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight

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

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 18 years:

  • apply to affected area
  • squeeze desired amount of Aspercreme® Heat Pain Relieving Gel onto affected area
  • using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed
  •  repeat as necessary, but no more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 18 years or younger: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice, capsaicin, DMDM hydantoin, fragrance, glycerin, methylparaben, phenoxyethanol, propylene glycol, propylparaben, SD alcohol 40-2 (15%), steareth-2, stereth-21, triethanolamine, water (245-202)

Principal Display Panel

Acts Fast • Lasts Long
Fast Acting for Minor
Arthritis, Joint &
Muscle Pain Relief
Fast Acting Therapy
Aspercreme Heat
Pain Relieving Gel
Menthol 10%
Net wt 2.5 oz (70.8 g)

Principal Display Panel Acts Fast • Lasts Long Fast Acting for Minor Arthritis, Joint & Muscle Pain Relief Fast Acting Therapy Aspercreme Heat Pain Relieving Gel Menthol 10% Net wt 2.5 oz (70.8 g)

ASPERCREME HEAT 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0574
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPSAICIN (UNII: S07O44R1ZM)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
NONOXYNOL-30 (UNII: JJX07DG188)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0574-01 in 1 CARTON12/01/199802/28/2022
173 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/199802/28/2022
Labeler - Chattem, Inc. (003336013)

Revised: 3/2022
Document Id: e89d327f-46c0-4b45-977f-5edb53dc3c0d
Set id: 569afe51-7918-4628-b248-c76c52b2abf1
Version: 4
Effective Time: 20220321
 
Chattem, Inc.