Label: MUSCLE RUB- menthol, methyl salicylate cream
- NDC Code(s): 68788-6857-8
- Packager: Preferred 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 November 1, 2019
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- Active ingredients
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
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
menthol, methyl salicylate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6857(NDC:45802-174) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 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:68788-6857-8 1 in 1 CARTON 12/22/2016 1 85 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 12/22/2016 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-6857)