OLP MUSCLE RUB- menthol, unspecified form gel

OLP MUSCLE RUB by

Drug Labeling and Warnings

OLP MUSCLE RUB by is a Otc medication manufactured, distributed, or labeled by OHIO LAB PHARMA LLC., OHIO LAB PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

menthol 2.5%

Purpose

Topical analgesic

USES

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

• simple backaches
• 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 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 your 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

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

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

vitamin E, propylene glycol, polysorbate 80, water, isopropyl alcohol, carbomer interpolymer type A, EDTA , methylparaben, propylparaben

Questions

ghassan@ohiolabpharma,com

Principal display panel 42.5 g tube carton

VANISHING SCENT
OLP MUSCLE RUB
MENTHOL PAIN RELIEVING GEL
NET WT. 1.5 OZ (42.5 g)

INGREDIENTS AND APPEARANCE

OLP MUSCLE RUB 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70648-000
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
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70648-000-01	1 in 1 CARTON	10/16/2016
1		42.5 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	10/16/2016

Labeler - OHIO LAB PHARMA LLC. (080215854)

Registrant - OHIO LAB PHARMA (080215854)

Establishment
Name	Address	ID/FEI	Business Operations
OHIO LAB PHARMA LLC.		080215854	manufacture(70648-000)