Label: ASPI-RUB PAIN RELIEVER- methyl salicylate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 69151-100-01 - Packager: AspiRub Enterprises LLC
- 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 August 29, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Inactive Ingredients
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WARNINGS
For external use only.
When using this product-
use only as directed, do not bandage tightly or use with a heating pad - avoid contact with eye and mucous membranes do not apply to wounds or damaged, broken or irritated skin.
- Directions
- Principal Display Panel
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
ASPI-RUB PAIN RELIEVER
methyl salicylate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69151-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 23 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) CASTOR OIL (UNII: D5340Y2I9G) WHITE PINE OIL (UNII: HA5CX6676U) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) PEPPERMINT OIL (UNII: AV092KU4JH) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) POLYSORBATE 20 (UNII: 7T1F30V5YH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69151-100-01 59 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/29/2014 Labeler - AspiRub Enterprises LLC (079478532) Establishment Name Address ID/FEI Business Operations AspiRub Enterprises LLC 079478532 manufacture(69151-100)