ASPERCREME HEAT

Main information

  • Trade name:
  • ASPERCREME HEAT- menthol gel
  • Composition:
  • MENTHOL 10 g in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ASPERCREME HEAT- menthol gel
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Topical analgesic temporarily relieves minor pain associated with: - arthritis - simple backache - muscle strains - sprains - bruises - cramps

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 41167-0574-0
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

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 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)

ASPERCREME HEAT

menthol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4116 7-0 574

Route of Administration

TOPICAL

Chattem, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

10 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

ALLANTO IN (UNII: 344S277G0 Z)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CAPSAICIN (UNII: S0 7O44R1ZM)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

STEARETH-2 (UNII: V56 DFE46 J5)

STEARETH-2 1 (UNII: 53J3F32P58 )

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4116 7-0 574-0

1 in 1 CARTON

1

73 mL in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

12/0 1/19 9 8

Labeler -

Chattem, Inc. (003336013)

Revised: 1/2014