ASPERCREME WARMING- capsaicin patch

Aspercreme Warming by

Drug Labeling and Warnings

Aspercreme Warming by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ASPERCREME WARMING 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1920
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	1.506 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1920-1	1 in 1 CARTON	01/02/2019
1		5 in 1 POUCH; 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	01/02/2019

Labeler - Chattem, Inc. (003336013)