DCH ARTHRITIS PAIN RELIEF ROLL-ON- capsaisin 0.1% gel

DCH Arthritis Pain Relief Roll-On by

Drug Labeling and Warnings

DCH Arthritis Pain Relief Roll-On by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Capsaicin 0.1%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporarily relieves minor pain associated with arthritis, simple backache, sprains, bruises, muscle strains, and cramps.

WARNINGS

For external use only.

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.

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, or irritation develops.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children of 18 years: 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. Children 18 years or younger: ask a doctor.

INACTIVE INGREDIENT

Alcohol denat., aminomethyl propanol, carbomer, glycerin, propylene glycol, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DCH ARTHRITIS PAIN RELIEF ROLL-ON 
capsaisin 0.1% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-026
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
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-026-03	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/20/2023

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72839-026)