POWER RELIEF- menthol gel

Power Relief by

Drug Labeling and Warnings

Power Relief by is a Otc medication manufactured, distributed, or labeled by Clientele, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredients

Menthol 2%

Purpose

Topical analgesic

Indications

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

• arthritis
• simple backache
• strains
• sprains
• bruises

Warnings

• For external use only.

• Avoid contact with the eyes.

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.

• Do not apply to wounds or damaged skin.
   
• Do not bandage tightly.

• Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years of age and older:
  apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age, consult a Physician.

Inactive Ingredients

Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

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Distributed exclusively by
American Herbal Products Corp.
North Bay Village, Florida

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

POWERRELIEF™
COOLING PAIN RELIEF ROLL ON

Net wt. 2 fl.oz (59.1 ml)
MADE IN USA

INGREDIENTS AND APPEARANCE

POWER RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64483-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET)	0.52 mL  in 100 mL
Water (UNII: 059QF0KO0R)	84.61 mL  in 100 mL
Eucalyptus oil (UNII: 2R04ONI662)	0.81 mL  in 100 mL

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64483-007-02	59 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/02/2004

Labeler - Clientele, Inc. (085021806)