Label: BUDPACK MUSCLE RUB- menthol gel
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated June 8, 2012
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
▪ 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
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BUDPACK MUSCLE RUB
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