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Rematex by Home Aide Diagnostics, Inc.

Medically reviewed on July 2, 2018

Dosage form: cream
Ingredients: MENTHOL 3g in 100g, HISTAMINE DIHYDROCHLORIDE 0.035g in 100g, CAPSAICIN 0.0375g in 100g
Labeler: Home Aide Diagnostics, Inc.
NDC Code: 69379-012

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.

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 relif 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
  • 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. 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.

REMATEX 
rematex pain relievingcream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69379-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3 g  in 100 g
HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE0.035 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:69379-012-01120 g in 1 BOTTLE, PUMP
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/FEIOperations
Zhejiang Bangli Medical Products Co. Ltd421295875manufacture(69379-012)

 
Home Aide Diagnostics, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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