MUSCLE RUB PAIN RELIEVER GEL- menthol, unspecified form gel

Muscle Rub Pain Reliever Gel by

Drug Labeling and Warnings

Muscle Rub Pain Reliever Gel by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Centre LLC, Savvy Care & Cosmetics Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Menthol 2.5%

Purpose

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Do not use

• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you haveredness over the affected area

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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: ask a doctor

Other information

store at 20° to 25°C (68° to 77°F)

Inactive ingredients

camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Questions?

call 1-800-223-0182(toll-free) or 215-273-8755(collect)

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

Extra Strength Muscle Rub

Pain Reliever Gel

Fast Penetrating

MENTHOL 2.5% TOPICAL ANALGESIC GEL

NET WT 1 OZ (35.4 g)

INGREDIENTS AND APPEARANCE

MUSCLE RUB PAIN RELIEVER GEL 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ISOCETETH-20 (UNII: O020065R7Z)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-072-04	1 in 1 CARTON	01/24/2021
1	NDC: 52000-072-03	35.4 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 Drug	M017	01/24/2021

Labeler - Universal Distribution Centre LLC (019180459)

Registrant - Savvy Care & Cosmetics Pvt. Ltd. (915039748)

Establishment
Name	Address	ID/FEI	Business Operations
Savvy Care & Cosmetics Pvt. Ltd.		915039748	manufacture(52000-072)