- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
-
WARNINGS
WARNINGS
FOR EXTERNAL USE ONLY.- Use only as directed
- Do not bandage tightly
- Do not use with a heating pad
- Avoid contact with the eyes or mucous membranes
- Do not apply to wounds, damaged, broken or irritated skin
- A transient burning sensation may occur upon application but generally disappears in several days
- If severe burning sensation occurs, discontinue use immediately and call a doctor
- Do not expose the area treated with product to heat or direct sunlight
-
DOSAGE & ADMINISTRATION
DIRECTIONS
- Adults and children over 18 years:
- Apply generously to affected area
- Massage into painful area until thoroughly absorbed into skin
- Repeat as necessary, not more than 3-4 times daily.
- Wash hands with soap and water immediately after use.
- Children 18 years or younger: ask a doctor
Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROTEX
rotex pain relieving cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69379-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 35 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.038 g in 100 g Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69379-038-01 120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/10/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/10/2015 Labeler - Home Aide Diagnostics, Inc. (783518983) Registrant - Zhejiang Bangli Medical Products Co. Ltd (421295875) Establishment Name Address ID/FEI Business Operations Zhejiang Bangli Medical Products Co. Ltd 421295875 manufacture(69379-038)