BUDPACK MUSCLE RUB- menthol gel

Budpack by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Menthol 2.5%

PURPOSE

Purpose
Topical Analgesic

INDICATIONS & USAGE

Uses ▪ Provides soothing relief of minor arthritis pain, aching muscles, joints and backache.

WARNINGS

Warnings

▪ 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

▪For external use only.Use only as directed. Keep out of the reach of children to avoid accidental poisoning.
▪If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

▪ Adults and children12 years of age and older: apply to affected area not more than 3-4 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 to 30C (59 to 86F) ▪ Lot No. Exp. Date: see box or see crimp of tube.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

BUDPACK  MUSCLE RUB
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-030
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: 27293-030-35	35 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/30/2012

Labeler - Budpack Inc. (183224849)

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