ASPERCREME WARMING NO MESS- capsaicin gel

Aspercreme Warming No Mess by

Drug Labeling and Warnings

Aspercreme Warming No Mess 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 GEL

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) or a medicated patch to the area of use

■ 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

■ do not expose the area treated with product to heat or direct sunlight

■ avoid applying into skin folds

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:

■ apply a thin layer to affected area

■ using the sponge-top applicator, massage dispensed gel into painful area until thoroughly absorbed

■ repeat if necessary, but no more than 3 to 4 times daily

■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children under 18 years of age: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, citric acid, disodium EDTA, ethylhexylglycerin, glycerin, methylparaben, propylene glycol, steareth-2, steareth-21, triethanolamine, water

Keep carton as it contains important information.

PRINCIPAL DISPLAY PANEL

Aspercreme
WARMING
PAIN RELIEVING GEL
NO MESS GEL
APPLICATOR
Net wt 2.5 oz (70.8 g)

INGREDIENTS AND APPEARANCE

ASPERCREME WARMING NO MESS 
capsaicin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1922
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.00025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1922-0	1 in 1 CARTON	03/05/2019
1		70.8 g in 1 TUBE; 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	03/05/2019

Labeler - Chattem, Inc. (003336013)