Label: MUSCLE RUB ULTRA STRENGTH- menthol and methyl salicylate cream
- NDC Code(s): 67234-002-01
- Packager: Natureplex LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated November 14, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Temporarily relieves minor aches and pains in muscles and joints associated with:
- simple backache
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
- 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, triethanolamineClose
- Questions or comments?
866-323-0107 or www.natureplex.comClose
- PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton
For Minor Arthritis, Backache, Muscle & Joint Pain
NET WT. 1.5 Oz.
- 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)