RETADOLOR PAIN RELIEF- capsaicin cream

RETADOLOR by

Drug Labeling and Warnings

RETADOLOR by is a Otc medication manufactured, distributed, or labeled by LACAR SALES & MARKETING INC., Concept Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

RETADOLOR   PAIN RELIEF
capsaicin cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - LACAR SALES & MARKETING INC. (795293435)

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