REMATEX- rematex pain relievingcream cream 
Home Aide Diagnostics, Inc.
Reference Label Set Id: 19c18a18-8b59-41ee-e054-00144ff88e88

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Silmanix Pain Relieiving Cream

ACTIVE INGREDIENTS


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

INDICATIONS


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

  • Simple Backache
  • Arthritis
  • Strains
  • Sprains
  • Bruises

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

DIRECTIONS

  • Clean and dry affected area
  • Apply to affected area
  • Store below 25 °C (77 °F). Avoid direct sunlight.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

  • This product may cause allergic reaction in some individuals.

INACTIVE INGREDIENTS

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

  • 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.

SILMANIX.jpg

REMATEX 
rematex pain relievingcream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69379-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69379-012-01120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2015
Labeler - Home Aide Diagnostics, Inc. (783518983)
Registrant - Zhejiang Bangli Medical Products Co. Ltd (421295875)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products Co. Ltd421295875manufacture(69379-012)

Revised: 7/2015
 
Home Aide Diagnostics, Inc.