CAREALL MUSCLE RUB ULTRA STRENGTH- menthol, methyl salicylate cream

CAREALL Muscle Rub by

Drug Labeling and Warnings

CAREALL Muscle Rub by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol

Methyl Salicylate

PURPOSE

Topical analgesic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center Immediately.

INDICATIONS & USAGE

Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS

For external use only

Do not use:

On wounds or damaged skin

With a heating pad

On a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have

redness over the affected area

When using this product

Avoid contact with eyes or mucous membrane

Do not bandage tightly

Stop use and ask a doctor if

Condition worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

DOSAGE & ADMINISTRATION

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

Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL MUSCLE RUB  ULTRA STRENGTH
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	100 mg  in 1 g
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ)	Methyl Salicylate	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Stearic Acid (UNII: 4ELV7Z65AP)
Trolamine (UNII: 9O3K93S3TK)
LANOLIN (UNII: 7EV65EAW6H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	white (White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-007-03	85 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2012

Labeler - New World Imports, Inc (075372276)