SOOTHING PAIN RELIEF ROLL ON- menthol, unspecified form gel

Soothing Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 of 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, Silica, Potassium Citrate, Magnesium Carbonate, Oleic Acid, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

Soothing
Pain Relief

Roll-On

2 Fl Oz (59.1 ml)

Rejuvenetics™

INGREDIENTS AND APPEARANCE

SOOTHING PAIN RELIEF   ROLL ON
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64483-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2 mg  in 100 mL

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

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64483-008-02	59.1 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/04/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/04/2014

Labeler - Clientele, Inc. (085021806)