Label: MUSCLE RUB- menthol, methyl salicylate cream
- NDC Code(s): 68071-1617-3
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 45802-174
- 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 March 21, 2019
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- Active ingredients
Methyl salicylate 15%Close
temporarily relieves the minor aches and pains of muscles and joints associated with
- simple backache
For external use only
Do not use
- other than as directed
- on children under 12 years of age
- with a heating pad (may blister skin)
When using this product
- avoid contact with the eyes or mucous membranes
- do not apply to wounds or damaged skin
- do not bandage tightly
Stop use and ask a doctor if
- skin redness or excessive irritation of the skin develops
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Keep out of reach of children
to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.
- adults & 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: consult a physician
- Other information
- store at 20°-25°C (68°-77°F)
- Lot No. & Exp. Date, see crimp of tube and see box
- Inactive ingredients
citric acid, glyceryl monostearate, lanolin, methylparaben, propylene glycol, propylparaben, purified water, stearic acid, trolamineClose
- Questions or comments?
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
menthol, methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-1617(NDC:45802-174) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-1617-3 85 g in 1 BOX; Type 0: Not a Combination Product 07/26/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/03/2011 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare pharmaceuticals,Inc. 010632300 relabel(68071-1617)