Drug Facts

Active ingredient	Purpose
Menthol 12%	Pain Relieving
Camphor 6%	Pain Relieving

Uses

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

simple backache
arthritis
strain
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 liberally 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 Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate.

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

RETADOLOR™
The Anti-Pain™

PENETRATING COOL THERAPY CREAM

Topical Analgesic for the Relief of
TENSION, STRAINS, SPRAINS
& MUSCLE PAIN

Contains Powerful
Menthol & Camphor
with Vanishing
Scent

ANTI-INFLAMMATORY
OMEGA
3, 6 & 9
with
IcePearls

NET WT. 3 OZ (85g)

Principal Display Panel - 85 g Bottle Label

RETADOLOR
menthol, unspecified form and camphor (synthetic) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69279-241
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.12 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALCOHOL (UNII: 3K9958V90M)
STARCH, CORN (UNII: O8232NY3SJ)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LINSEED OIL (UNII: 84XB4DV00W)
ROSEMARY OIL (UNII: 8LGU7VM393)
ACAI OIL (UNII: Z0W6766A2W)
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
LAURYL LAURATE (UNII: GPW77G0937)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69279-241-13	85 g in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2017
2	NDC:69279-241-44	113 g in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	02/08/2017

Labeler - LACAR SALES & MARKETING INC. (795293435)

Registrant - Concept Laboratories, Inc. (962282612)

Name	Address	ID/FEI	Business Operations
Establishment
Concept Laboratories, Inc.		962282612	MANUFACTURE(69279-241)