REMATEX- rematex pain relieiving cream cream

Rematex by

Drug Labeling and Warnings

Rematex by is a Prescription medication manufactured, distributed, or labeled by Home Aide Diganostics, Inc., Zhejiang Bangli Medical Products Cl. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INFORMATION FOR PATIENTS

PURPOSE:

Topical analgesic

ACTIVE INGREDIENTS
Mehyl Salicylate 30% ------------------------------------------------------------------------------------------------ Counterirritant
Menthol 6% --------------------------------------------------------------------------------------------------------- Topical analgesic
Capsaicin 0.035% ------------------------------------------------------------------------------------------------- Topical analgesic

INDICATIONS & USAGE

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

• Arthritis
• Simple Backache
• Strains
• Sprains
• Bruises

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.

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

WARNINGS AND PRECAUTIONS

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

OTHER SAFETY INFORMATION

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

REMATEX 
rematex pain relieiving cream cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69379-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.035 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69379-002-03	120 g in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/10/2015

Labeler - Home Aide Diganostics, Inc. (783518983)

Registrant - Zhejiang Bangli Medical Products Cl. Ltd. (421295875)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Bangli Medical Products Cl. Ltd.		421295875	manufacture(69379-002)