MAKESENSE EXTRA STRENGTH MUSCLE RUB- menthol gel

MakeSense by

Drug Labeling and Warnings

MakeSense by is a Otc medication manufactured, distributed, or labeled by Cherry Hill Sales Co, Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 2.5%

Purpose

Topical Analgesic

Uses

■ temporarily relieves the minor arthritis pains of muscles and joints associated with ■ simple backache ■ bruises ■arthritis ■strains ■sprains

Warnings

For external use only. Flammable: Keep away from fire or flame

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 have redness 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 ■ you have redness over the affected area

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ adults and children12 years of age and older: apply to affected area not more than 3-4 times 

■ children under 12 years of age: ask a doctor

Other information

■ store at room temperature 20 to 25C (68 to 77F)

Inactive Ingredients

Camphor, Carbomer, DMDM Hydantoin, Isoceteth, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide and Water

Package Label

INGREDIENTS AND APPEARANCE

MAKESENSE  EXTRA STRENGTH MUSCLE RUB
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69020-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DMDM HYDANTOIN (UNII: BYR0546TOW)
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: 69020-200-15	42.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2014

Labeler - Cherry Hill Sales Co (145959768)

Establishment
Name	Address	ID/FEI	Business Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.		529836561	manufacture(69020-200)