RETADOLOR (menthol and camphor- synthetic cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A), Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)

Available from:

Concept Laboratories, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for the temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - sprains - bruises

Authorization status:

OTC monograph final

Summary of Product characteristics

RETADOLOR PENETRATING COOL THERAPY- MENTHOL AND CAMPHOR (SYNTHETIC)
CREAM
CONCEPT LABORATORIES, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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RETADOLOR
THE ANTI-PAIN
PENETRATING COOL THERAPY CREAM
ACTIVE INGREDIENT
PURPOS E
Menthol 12%
Pain Relieving
Camphor 6%
Pain Relieving
US ES
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
Exclu