MUSCLE RUB  ULTRA STRENGTH- menthol and methyl salicylate cream 
Natureplex LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Muscle Rub Ultra Strength
Topical Analgesic

Drug Facts

Active ingredientsPurpose
Menthol 1%Topical analgesic
Methyl salicylate 15%Topical analgesic

Use

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

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

Other information

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)

Principal Display Panel - 42.5 g Tube Carton
MUSCLE RUB   ULTRA STRENGTH
menthol and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.01 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-002-011 in 1 BOX01/02/2007
142 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/02/2007
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-002)

Revised: 11/2017
Document Id: 89f0e6ea-4368-417a-ad0b-9b02e69e588e
Set id: dfdba5d0-e505-4c87-adb4-541e05de9981
Version: 2
Effective Time: 20171114
 
Natureplex LLC