RETADOLOR (menthol and camphor- synthetic cream

Retadolor by

Drug Labeling and Warnings

Retadolor by is a Otc medication manufactured, distributed, or labeled by Concept Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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
• 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 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), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, 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, Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octrenylsuccinate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate

SPL UNCLASSIFIED SECTION

Exclusively manufactured for
LaCar Sales & Marketing Inc.
by Concept Laboratories, Inc.
Chicago, IL 60642
www.retadolor.com
#CL9957

PRINCIPAL DISPLAY PANEL - 85g Bottle Label

RETADOLOR
NDC: 64058-241-13
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)

INGREDIENTS AND APPEARANCE

RETADOLOR   PENETRATING COOL THERAPY
menthol and camphor (synthetic) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64058-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	10.2 g  in 85 g
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	5.1 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
LAURYL LAURATE (UNII: GPW77G0937)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALCOHOL (UNII: 3K9958V90M)
LINSEED OIL (UNII: 84XB4DV00W)
ROSEMARY OIL (UNII: 8LGU7VM393)
ACAI OIL (UNII: Z0W6766A2W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64058-241-13	85 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part348	07/27/2009

Labeler - Concept Laboratories, Inc. (962282612)

Establishment
Name	Address	ID/FEI	Business Operations
Concept Laboratories, Inc.		962282612	MANUFACTURE