SIMANIX- simanix pain relieving cream cream 
Home Aide Diagnostics, Inc.
Reference Label Set Id: 1a4afc2e-1d77-2243-e054-00144ff88e88

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Silmanix Pain Relieiving Cream

PURPOSE: Topical analgesic

ACTIVE INGREDIENTS
Capsaicin 0.0357% --------------------------------------------------------------------------------------------------- Counterirritant
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Histamine DiHydrochloride% ----------------------------------------------------------------------------------- Topical analgesic

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

WARNINGS
FOR EXTERNAL USE ONLY.

STOP USE AND ASK A DOCTOR IF:

DIRECTIONS

Store at 20°-25°C (68°-77 °F). Avoid direct sunlight.

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

SILMANIXRX.jpg

SIMANIX 
simanix pain relieving cream cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69379-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0357 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE0.035 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69379-013-02120 g in 1 BOTTLE; Type 0: Not a Combination Product07/08/201507/08/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/08/2015
Labeler - Home Aide Diagnostics, Inc. (783518983)
Registrant - Zhejiang Bangli Medical Products Cl. Ltd (421295875)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products Co. Ltd421295875manufacture(69379-013)

Revised: 7/2015
Document Id: 1a4dfef7-a7ad-2142-e054-00144ff8d46c
Set id: 1a4dfef7-a7ac-2142-e054-00144ff8d46c
Version: 2
Effective Time: 20150707
 
Home Aide Diagnostics, Inc.