Label: EAGLE MEDICATED AROMATIC- camphor menthol methyl salicylate oil
- NDC Code(s): 60954-007-03, 60954-007-08, 60954-007-12, 60954-007-24
- Packager: Eagle Indo Pharma, PT
- Category: HUMAN OTC DRUG LABEL
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 June 27, 2022
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- Active Ingredients
- Purpose
- Uses
- Warning
- Do not use
- Ask a doctor before use if
- When using this product
- Stop use and ask a doctor if
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INGREDIENTS AND APPEARANCE
EAGLE MEDICATED AROMATIC
camphor menthol methyl salicylate oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60954-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 7 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 35 g in 100 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) LIGHT MINERAL OIL (UNII: N6K5787QVP) SPIKE LAVENDER OIL (UNII: 7S2HYV1VJQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60954-007-24 1 in 1 BOX 06/20/2022 1 24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 2 NDC:60954-007-03 1 in 1 BOX 06/20/2022 2 3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 3 NDC:60954-007-08 1 in 1 BOX 06/20/2022 3 8 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 4 NDC:60954-007-12 1 in 1 BOX 06/20/2022 4 12 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 06/20/2022 Labeler - Eagle Indo Pharma, PT (728682519) Establishment Name Address ID/FEI Business Operations Eagle Indo Pharma, PT 728682519 manufacture(60954-007)