Label: BUDPAK MUSCLE RUB- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 27293-018-01, 27293-018-35 - Packager: Budpak Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Drug Label Information
Updated November 24, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BUDPAK MUSCLE RUB
menthol gelProduct 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)