ULTRA STRENGHT MUSCLE RUB- methyl salicylate, menthol cream

Ultra Strenght Muscle Rub by

Drug Labeling and Warnings

Ultra Strenght Muscle Rub by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol - 8.00%

Methyl Salicylate - 30.00%

PURPOSE

Purpose

Menthol - 8.00% .................................................. External Analgesic

Methyl Salicylate - 30.00% ................................. External Analgesic

INDICATIONS & USAGE

Uses Temporary relief for minor aches and pains of muscles and joints.

WARNINGS

Warnings

For external use only, Do not bandage tightly, apply to wounds or damaged skin or use with a heating pad.

STOP USE

Caution: Discontinue use if excessive irritation of skin develops, Avoid getting into eyes or mucous membranes, If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental poisoning, if swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

Use only as directed. Adults and children 12 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Ask a doctor.

INACTIVE INGREDIENT

DEA-Cetyl Phosphate

Glyceryl Stearate

Lanolin

Potassium Stearate

Stearic Acid

Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA STRENGHT MUSCLE RUB 
methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-010
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	8 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM STEARATE (UNII: 17V812XK50)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PHOSPHATE (UNII: VT07D6X67O)
WATER (UNII: 059QF0KO0R)
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-010-01	113 mL in 1 TUBE; Type 0: Not a Combination Product	05/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/07/2019

Labeler - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-010)