ROTEX- rotex pain relieving cream cream

Rotex by

Drug Labeling and Warnings

Rotex by is a Otc medication manufactured, distributed, or labeled by Home Aide Diagnostics, Inc., Zhejiang Bangli Medical Products Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

PURPOSE: Topical analgesic

ACTIVE INGREDIENT

ACTIVE INGREDIENTS
Methyl Salicylate 35% ----------------------------- Counterirritant
Capsaicin 0.038% ----------------------------------- Counterirritant
Menthol 4% ---------------------------------------- Topical analgesic

INDICATIONS & USAGE

INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:

• Arthritis
• Simple Backache
• Strains
• Sprains
• Bruises

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

STOP USE AND ASK A DOCTOR IF:

• Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
• Redness is present or irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

PREGNANCY OR BREAST FEEDING

If pregnant of breast-feeding, ask a healthcare professional before use

INACTIVE INGREDIENT

INACTIVE INGREDIENTS
aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROTEX 
rotex pain relieving cream cream

Product 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)