SIMANIX- simanix pain relieving cream cream

Simanix by

Drug Labeling and Warnings

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

Drug Details [pdf]

INFORMATION FOR PATIENTS

PURPOSE: Topical analgesic

INFORMATION FOR PATIENTS

ACTIVE INGREDIENTS
Capsaicin 0.0375% --------------------------------------------------------------------------------------------------- Counterirritant
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Histamine DiHydrochloride0.035% ----------------------------------------------------------------------------------- Topical analgesic

INDICATIONS & USAGE

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

• Arthritis
• Simple Backache
• Strains
• Sprains
• Bruises

WARNINGS AND PRECAUTIONS

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

INDICATIONS & USAGE

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.

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)

OTHER SAFETY INFORMATION

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

SIMANIX 
simanix pain relieving cream cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69379-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0375 g  in 100 g
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69379-001-03	120 g in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/08/2015

Labeler - Home Aide Diagnostics, Inc. (783518983)

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Bangli Medical Products Co. Ltd		421295875	manufacture(69379-001)