BUDPACK MUSCLE RUB- menthol gel 
Budpack Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients
Menthol 2.5%

Purpose
Topical Analgesic

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

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.

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

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

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

Package Label
image of package label


BUDPACK  MUSCLE RUB
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-030-3535 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2012
Labeler - Budpack Inc. (183224849)
Establishment
NameAddressID/FEIBusiness Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture

Revised: 6/2012
Document Id: b2cd9dd8-f8e2-4160-8366-bedb2f9dd25f
Set id: 5578e67a-f0f5-4204-8455-70592c2f4dfa
Version: 1
Effective Time: 20120608
 
Budpack Inc.