Label: ARTREX- camphor, menthol, and turpentine cream
- NDC Code(s): 68354-131-10, 68354-131-60
- Packager: Bioved Pharmaceuticals
- 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 September 30, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
- Do not apply to wound or damaged skin
- Do not bandage tightly
- Do not swallow. If swallowed call a physician or contact a poison control center immediately
- Keep away from eyes, mucous membranes, broken or irritated skin
- If skin redness or irritation develops or pain lasts more than 10 days, discontinue use and call a physician
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- Artrex 60g Tube
-
INGREDIENTS AND APPEARANCE
ARTREX
camphor, menthol, and turpentine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68354-131 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3 g in 60 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.8 g in 60 g TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G) TURPENTINE 6 g in 60 g Inactive Ingredients Ingredient Name Strength METHYL SALICYLATE (UNII: LAV5U5022Y) EUCALYPTUS OIL (UNII: 2R04ONI662) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) CINNAMON OIL (UNII: E5GY4I6YCZ) ROSE OIL (UNII: WUB68Y35M7) GINGER OIL (UNII: SAS9Z1SVUK) THYMOL (UNII: 3J50XA376E) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68354-131-60 60 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2014 2 NDC:68354-131-10 10 g in 1 TUBE; Type 0: Not a Combination Product 08/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2004 Labeler - Bioved Pharmaceuticals (131537917) Establishment Name Address ID/FEI Business Operations Bioved Pharmaceuticals Inc. 131537917 manufacture(68354-131)