RED OIL- menthol and camphor oil

Red Oil by

Drug Labeling and Warnings

Red Oil by is a Otc medication manufactured, distributed, or labeled by The Red Oil Company, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actives

Camphor 1 %

Menthol 1%

Purpose

External Analgesic

SPL UNCLASSIFIED SECTION

Indication

Temporary relief from pain and itiching associated with minor skin irritations , insect bites, minor burns or sun burns, posion oak and minor reactions due to use of soaps, detergents or cosmetics.

INACTIVE INGREDIENT

Directions

Apply directly to affected area

Do not use more than four times per day

WARNINGS

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RED OIL 
menthol and camphor oil

Product 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)