RUGBY MUSCLE RUB CREAM- muscle rub cream cream 
Rugby Laboratories

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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Drug Facts

Active Ingredients

Menthol - 10%

Methyl salicylate - 15%

Purpose

Topical Analgesic

Topical Analgesic

Uses

Warnings

For external use only

Avoid contact with eyes and mucous membranes

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Store at controlled room temperature 68°- 77°F ( 20° to 25°C) Close cap tightly afteruse.

Inactive ingredients

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Stearic acid, Triethanolamine, Purified Water

Principal Display Panel - 3.0 oz Carton

Rugby

Greaseless

MUSCLE RUB Cream

10% Menthol / 15% Methyl Salicylate

Topical Analgesic

Net WT. 3.0 OZ (85g)

Principal Display Panel - 3.0 oz Carton

Principal Display Panel -  3.0 oz Tube

Rugby

Greaseless

MUSCLE RUB Cream

10% Menthol / 15% Methyl Salicylate

Topical Analgesic

Net WT. 3.0 OZ (85g)

Principal Display Panel - 3.0 oz Tube

RUGBY MUSCLE RUB CREAM 
muscle rub cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1349
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1349-571 in 1 CARTON02/28/2022
185 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 finalpart34802/28/2022
Labeler - Rugby Laboratories (079246066)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(0536-1349)

Revised: 2/2022
Document Id: 0062d73b-5a92-4535-97fd-785902139c15
Set id: 7c6f49d9-0ecd-494a-abd3-cdda6d6e5d06
Version: 1
Effective Time: 20220203
 
Rugby Laboratories