Label: EAGLE MEDICATED- menthol methyl salicylate oil
- NDC Code(s): 60954-008-03, 60954-008-08, 60954-008-24, 60954-008-36
- Packager: Eagle Indo Pharma
- 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 July 1, 2022
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- Active Ingredients
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- Warning
- Do not use
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INGREDIENTS AND APPEARANCE
EAGLE MEDICATED
menthol methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60954-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14.5 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g in 100 mL Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 11 (UNII: 44F3HYL954) D&C GREEN NO. 6 (UNII: 4QP5U84YF7) ALCOHOL (UNII: 3K9958V90M) MINERAL OIL (UNII: T5L8T28FGP) ROSE OIL (UNII: WUB68Y35M7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60954-008-24 1 in 1 BOX 06/27/2022 1 24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:60954-008-36 1 in 1 BOX 06/27/2022 2 36 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 3 NDC:60954-008-03 1 in 1 BOX 06/27/2022 3 3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 4 NDC:60954-008-08 1 in 1 BOX 06/27/2022 4 8 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/20/2012 Labeler - Eagle Indo Pharma (728682519) Establishment Name Address ID/FEI Business Operations Eagle Indo Pharma 728682519 manufacture(60954-008)