REMATEX- rematex pain relievingcream cream

Rematex by

Drug Labeling and Warnings

Rematex 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]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

Histamine Dihydrochloride 0.035% ---------------------------------------------------------------------------------Topical analgesic
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Capsaicin 0.0375% ------------------------------------------------------------------------------------------------- Topical analgesic

PURPOSE

INDICATIONS

For the temporary relif of minor aches and pains of muscles and joints associated with:

• Simple Backache
• Arthritis
• Strains
• Sprains
• Bruises

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY.

• Avoid contact with eyes.
• If condition worsens, of if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a s physician.
• Do not apply to wounds or damaged skin
• Do not bandage tightly

DOSAGE & ADMINISTRATION

DIRECTIONS

• Clean and dry affected area
• Remove patch from backing and apply to affected area
• Use only one patch at a time and maximum of four patches daily
• Leave patch on affected area for up to 8-hours
• Do not use patches for longer than 5 consecutive days unless directed by a physician.
• Store below 25 °C (77 °F). Avoid direct sunlight.

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.

PREGNANCY OR BREAST FEEDING

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

• This product may cause allergic reaction in some individuals.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose Sodium; water;

INDICATIONS & USAGE

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: consult a physician.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REMATEX 
rematex pain relievingcream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69379-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	0.035 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 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: 69379-012-01	120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2015

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(69379-012)