Label: ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69274-002-01, 69274-002-02, 69274-002-03, 69274-002-04, view more69274-002-05, 69274-002-06, 69274-002-07 - Packager: FOUR SEASONS TRADING INC
- 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.
Drug Label Information
Updated November 25, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69274-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 50 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL SALICYLATE (UNII: LAV5U5022Y) PEG-75 LANOLIN (UNII: 09179OX7TB) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69274-002-01 118 mL in 1 BOTTLE, PLASTIC 2 NDC:69274-002-02 177 mL in 1 BOTTLE, PLASTIC 3 NDC:69274-002-03 237 mL in 1 BOTTLE, PLASTIC 4 NDC:69274-002-04 296 mL in 1 BOTTLE, PLASTIC 5 NDC:69274-002-05 354 mL in 1 BOTTLE, PLASTIC 6 NDC:69274-002-06 414 mL in 1 BOTTLE, PLASTIC 7 NDC:69274-002-07 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/25/2014 Labeler - FOUR SEASONS TRADING INC (169331464) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(69274-002)
