Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

simple backache
arthritis
strains
sprains
bruises

Warnings

For external use only.

do not apply to wounds or damaged skin
do not bandage tightly

When using this product do not get into eyes

avoid contact with other mucous membranes

Flammable

Keep from heat and flame.

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control center right away

if pregnant or nursing, seek the advice of a health professional before using

Directions

Apply a thin layer to affected area not more than 4 times daily unless otherwise directed by your physician or pharmacist
Gently massage into the skin until fully absorbed
Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

RETADOLOR™
The Anti-Pain™

PENETRATING HEAT THERAPY CREAM

Topical Analgesic for the Relief of
ARTHRITIS, JOINT PAIN, MUSCLE
ACHES AND CRAMPS

#1
Contains
Capsaicin
Recommended
by Doctors

ANTI-INFLAMMATORY
OMEGA
3, 6 & 9
with
IcePearls

NET WT 3 OZ. (85g)

Principal Display Panel - 85 g Bottle Label

RETADOLOR PAIN RELIEF
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69279-144
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM)	Capsaicin	0.25 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
LAURYL LAURATE (UNII: GPW77G0937)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
STARCH, CORN (UNII: O8232NY3SJ)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
PEPPERMINT OIL (UNII: AV092KU4JH)
LINSEED OIL (UNII: 84XB4DV00W)
ACAI OIL (UNII: Z0W6766A2W)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
ROSEMARY OIL (UNII: 8LGU7VM393)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69279-144-13	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	08/07/2015

Labeler - LACAR SALES & MARKETING INC. (795293435)

Name	Address	ID/FEI	Business Operations
Establishment
Concept Laboratories, Inc.		962282612	MANUFACTURE(69279-144)

RETADOLOR™ Pain Relief