ASPERCREME WARMING- capsaicin patch 
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 Warming Patch

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

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)

Revised: 1/2019
Document Id: c337e43f-c660-4ce8-a0b1-78c1c2d54a77
Set id: 7db7684c-fdc4-40f3-a2c0-e05e68bf417b
Version: 3
Effective Time: 20190102
 
Chattem, Inc.