Label: RUGBY MUSCLE RUB CREAM- muscle rub cream cream
- NDC Code(s): 0536-1349-57
- Packager: Rugby Laboratories
- 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.
Drug Label Information
Updated February 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
Avoid contact with eyes and mucous membranes
- If conditions worsens, or if symtoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
- Do not apply to wounds or damaged skin.
- Do not apply bandage tightly.
- Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin.
- Discontinue use if excessive irritation of skin develops.
- If pregnant or breast feeding, ask a health professional before use.
- A temporary burning sensation may occur upon application, but generally disappears in a few days.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel - 3.0 oz Carton
- Principal Display Panel - 3.0 oz Tube
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INGREDIENTS AND APPEARANCE
RUGBY MUSCLE RUB CREAM
muscle rub cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1349 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 100 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER 940 (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1349-57 1 in 1 CARTON 02/28/2022 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 02/28/2022 Labeler - Rugby Laboratories (079246066) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(0536-1349)
