MUSCLE RUB ULTRA STRENGTH- menthol and methyl salicylate cream

Muscle Rub by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Menthol 1%	Topical analgesic
Methyl salicylate 15%	Topical analgesic

Use

Temporarily relieves minor aches and pains in muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years old with arthritis-like conditions
• if seal on tube is punctured or missing

Stop use and ask a doctor if

• excessive skin irritation occurs
• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

Ask a doctor before use

• if the affected area is red
• if pregnant or breast-feeding
• for children under 2 years old
• for children up to 12 years old if prone to allergic reaction from or if sensitive to aspirin or salicylate

When using this product

• do not bandage or wrap tightly
• avoid contact with eyes or mucous membranes

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

• use only as directed
• adults and children 12 years old and older: apply to affected area up to 4 times daily
• children under 12 years old: ask a doctor

Other information

• store at 15 to 30°C (59 to 86°F)
• close cap tightly after use

Inactive ingredients

Carbomer, cetearyl alcohol and polysorbate 60, cetyl alcohol, glycerin, methylparaben, mineral oil, propylene glycol, propylparaben, purified water, triethanolamine

Questions or comments?

866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

Natureplex™

Ultra Strength
MuscleRub
For Minor Arthritis, Backache, Muscle & Joint Pain

NET WT. 1.5 Oz.
(42.5g)

INGREDIENTS AND APPEARANCE

MUSCLE RUB   ULTRA STRENGTH
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67234-002
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	0.01 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67234-002-01	1 in 1 BOX	01/02/2007
1		42 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/02/2007

Labeler - Natureplex LLC (062808196)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(67234-002)