THERMACARE ARTHRITIS AND NERVE PAIN THERAPY CAPSAICIN ROLL ON- thermacare capsaicin roll on liquid

Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On by

Drug Labeling and Warnings

Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On by is a Otc medication manufactured, distributed, or labeled by Clarion Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Capsaicin 0.1%

PURPOSE

Topical analgesic

INDICATIONS & USAGE

For temporary relief of minor aches and pains of muscles and joints associated with:

• arthritis
• muscle strains
• sprains
• bruises
• simple backache

WARNINGS

For external use only

Flammable

• keep away from excessive heat or open flame

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

WHEN USING

When using this product

• do not bandage tightly or cover treated area
• do not use with heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight

Directions adults and children over 18 years of age:

• apply to affected area
• massage into painful area until thoroughly absorbed
• repeat as necessary, but no more than 3 to 4 times daily
• wash hands with soap and water after applying

INACTIVE INGREDIENT

alcohol denatured

aminomethyl propanol

carbomer

glycerin

propylene glycol

water

QUESTIONS

call 1-800-323-3383

DOSAGE & ADMINISTRATION

Capsaicin 0.1%

Topical analgesic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Children 18 years of age or younger: ask a doctor

PRINCIPAL DISPLAY PANEL

Thermacare Heat Therapy™

Penetraing CAPSAICIN soothes nerves

ARTHRITIS & NERVE PAIN THERAPY

CAPSAICIN ROLL ON

Soothes Aggravated Nerves

Deep Penetrating Warmth

Long Lasting, Fast Acting

0.1% Capsaicin

No Mess Roll On

NET WT. 2.5 oz (70.8 g)

INGREDIENTS AND APPEARANCE

THERMACARE ARTHRITIS AND NERVE PAIN THERAPY CAPSAICIN ROLL ON 
thermacare capsaicin roll on liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69693-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape	ROUND (Cylindrical Container)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69693-001-25	70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/09/2024

Labeler - Clarion Brands LLC (079742703)