MUSCLE RUB ULTRA STRENGTH CVS- camphor 4% menthol 10% methyl salicylate 30% cream
CVS

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 Purpose

Camphor – 4%                              External Analgesic
Menthol – 10%                             External Analgesic
Methyl Salicylate – 30%            External Analgesic

Uses

For temporarily relief of minor aches and pains of muscles and joints

Warnings
For external use only

When using this product • avoid contact with eyes and mucous membranes • do not bandage tightly

Do not use • on wounds or damaged skin • in large quantities, particularity over raw surfaces • with a healing pad

When using this product • avoid contact with eyes and mucous membranes • do not bandage tightly

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days

• simptoms clear up and occur again within a few days

• excessive skin irritation occurs

Keep out of reach of the children to avoid accidental ingestion.
If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply only as directed.

• adults and 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 doctor

• close cap tightly after use

Other information

Store at control room temperature 15o - 30oC (59o - 86oF)

Inactive ingredients

Carbomer, Disodium EDTA, Glyceryl Stearate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Purified Water, Stearic Acid, Trolamine

image description

MUSCLE RUB ULTRA STRENGTH CVS
camphor 4% menthol 10% methyl salicylate 30% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-297
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
Lanolin (UNII: 7EV65EAW6H)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Potassium Hydroxide (UNII: WZH3C48M4T)
Water (UNII: 059QF0KO0R)
Stearic Acid (UNII: 4ELV7Z65AP)
Trolamine (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-297-02	1 in 1 CARTON	12/17/2014	12/29/2017
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/17/2014	12/29/2017

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(59779-297)

Revised: 12/2017

Document Id: 646e6396-1864-4a9a-b972-31c831dfafda

Set id: 9dd3a37d-d726-4764-a3f6-39af38711d7c

Version: 3

Effective Time: 20171229

CVS