FDA Label for Retadolor Penetrating Cool Therapy

View Indications, Usage & Precautions

Retadolor Penetrating Cool Therapy Product Label

The following document was submitted to the FDA by the labeler of this product Concept Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



Active ingredientPurpose
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.


Otc - Do Not Use



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

Otc - When Using



When using this product do not get into eyes

  • avoid contact with other mucous membranes
  • Flammable: Keep from heat and flame.


Otc - Stop Use



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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

Otc - Pregnancy Or Breast Feeding



  • 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


Other



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)


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