Label: RED OIL- menthol and camphor oil
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Contains inactivated NDC Code(s)
NDC Code(s): 70537-001-02, 70537-001-08, 70537-001-16 - Packager: The Red Oil Company
- 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 January 24, 2020
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- Official Label (Printer Friendly)
- Actives
- Purpose
- SPL UNCLASSIFIED SECTION
- Indication
- INACTIVE INGREDIENT
- Directions
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RED OIL
menthol and camphor oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70537-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) ACETONE (UNII: 1364PS73AF) WHITE PINE OIL (UNII: HA5CX6676U) ISOPROPYL ALCOHOL (UNII: ND2M416302) BENZOCAINE (UNII: U3RSY48JW5) CHLOROTHYMOL (UNII: LJ25TI0CVT) PHENOL (UNII: 339NCG44TV) Product Characteristics Color red (D&C Red #17) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70537-001-08 237 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/04/2016 2 NDC:70537-001-16 473 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/04/2016 3 NDC:70537-001-02 59 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/04/2016 Labeler - The Red Oil Company (011947497) Registrant - The Red Oil Company (011947497) Establishment Name Address ID/FEI Business Operations Filltech USA, LLC 926433855 manufacture(70537-001)
