Aspercreme Max No Mess Roll on

Aspercreme Max No Mess Roll On by

Drug Labeling and Warnings

Aspercreme Max No Mess Roll On by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 1, Chattem Plant 2. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASPERCREME MAX NO MESS ROLL ON- menthol liquid 
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 Max No Mess Roll on

Aspercreme® Max No Mess Roll-on

Active Ingredient:

Menthol 16%

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

Flammable

•  Keep away from fire or flame.

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
  
• IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, SD alcohol 40 (30%), triethanolamine, water (245-256)

Close cap tightly after use. Keep carton as it contains important information.

Distributed by: Chattem, Inc.

P.O. Box 2219

Chattanooga, TN 37409-0219

0043104-01       U.S.A. ©2009        www.chattem.com        Recyclable Carton

Principal Display Panel

NEW!

Powerful

Heating Action

ARTHRITIS STRENGTH

Aspercreme®

Max No-Mess

Roll-On Menthol 16%

Roller Ball Keeps Hands Clean

With

Skin conditioners

Pain Relieving Liquid

2.5 FL OZ (73 ML)

ASPERCREME MAX NO MESS ROLL ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0575
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.16 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPSAICIN (UNII: S07O44R1ZM)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0575-0	1 in 1 CARTON	12/01/2009	11/01/2019
1		73 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/01/2009	11/01/2019

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS(41167-0575) , LABEL(41167-0575) , MANUFACTURE(41167-0575) , PACK(41167-0575)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	LABEL(41167-0575) , MANUFACTURE(41167-0575) , PACK(41167-0575)

Revised: 12/2009

Document Id: edcc994e-5d00-4488-9df4-08ba750bedd8

34390-5

Set id: d4914b74-3447-49dd-a613-595ddb4b61a3

Version: 3

Effective Time: 20091201

 

Chattem, Inc.