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Rematex Cream

Generic Name: menthol, methyl salicylate, capsaicin
Dosage Form: cream

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.

PURPOSE:

Topical analgesic

ACTIVE INGREDIENTS
Mehyl Salicylate 30% ------------------------------------------------------------------------------------------------ Counterirritant
Menthol 6% - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Topical analgesic
Capsaicin 0.035% ------------------------------------------------------------------------------------------------- Topical analgesic

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

  • Arthritis
  • Simple Backache
  • Strains
  • Sprains
  • Bruises

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.

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

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; odium; water

REMATEX 
rematex pain relieiving cream cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69379-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 6 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.035 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 30 g  in 100 g
Packaging
# Item Code Package Description
1 NDC:69379-002-03 120 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/10/2015
Labeler - Home Aide Diganostics, Inc. (783518983)
Registrant - Zhejiang Bangli Medical Products Cl. Ltd. (421295875)
Establishment
Name Address ID/FEI Operations
Zhejiang Bangli Medical Products Cl. Ltd. 421295875 manufacture(69379-002)
Revised: 07/2015
 
Home Aide Diganostics, Inc.



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