BUDPAK MUSCLE RUB- menthol gel

Budpak Muscle Rub by

Drug Labeling and Warnings

Budpak Muscle Rub by is a Otc medication manufactured, distributed, or labeled by Budpak Inc., Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol 2.5%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

• Provides soothing relief of minor arthritis pain, aching muscles, joints and backaches.

WARNINGS

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

• Avoid contact with eyes or mucous membranes.
• Discontinue use if excessive irritation of the skin develops.
• Do not bandage tightly, apply to wounds, broken or irritated skin, or use with a heating pad.
• If condition worsens, or if symptoms persist for more than 10 days or clear-up and occur again within a few days, if skin redness or irritation develops, discontinue use of this product and consult a doctor.
• For arthritis like conditions in children under 12, do not use. Consult a doctor.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily and gently massage until gel disappears.
• Children under 12 years of age: do not use, consult a doctor

SPL UNCLASSIFIED SECTION

Other Information

• Store at controlled room temperature 15°C to 30°C (59°F to 86°F)
• Lot No. Exp. Date: see crimp of tube.

INACTIVE INGREDIENT

Inactive Ingredients

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

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

BUDPAK MUSCLE RUB

FAST PENETRATING RELIEF

NET WT 1.25 OZ (35 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK MUSCLE RUB 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.025 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 940 (UNII: 4Q93RCW27E)
DMDM HYDANTOIN (UNII: BYR0546TOW)
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: 27293-018-01	1 in 1 BOX
1	NDC: 27293-018-35	35 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	12/17/2012

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-018)