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Rematex by Home Aide Diagnostics, Inc.

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

PURPOSE: Topical analgesic

ACTIVE INGREDIENTS


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

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

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises

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

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.

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

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 Sodium; water;

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)

Revised: 07/2015
 
Home Aide Diagnostics, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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