Muscle Rub Ultra Strength (Menthol And Methyl Salicylate) Cream [Natureplex Llc] -

MUSCLE RUB ULTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) CREAM [NATUREPLEX LLC]
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NDC	67234-002-01
Set ID	dfdba5d0-e505-4c87-adb4-541e05de9981
Category	HUMAN OTC DRUG LABEL
Packager	Natureplex LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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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)

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/02/2007

Labeler - Natureplex LLC (062808196)

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

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Medic

MUSCLE RUB ULTRA STRENGTH (MENTHOL AND METHYL SALICYLATE) CREAM [NATUREPLEX LLC]

Do not use

Stop use and ask a doctor if

Ask a doctor before use

When using this product

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