Label: SIMANIX- simanix pain relieving cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69379-013-02 - Packager: Home Aide Diagnostics, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated July 7, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INFORMATION FOR PATIENTS
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INFORMATION FOR PATIENTS
ACTIVE INGREDIENTS
Capsaicin 0.0357% --------------------------------------------------------------------------------------------------- Counterirritant
Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic
Histamine DiHydrochloride% ----------------------------------------------------------------------------------- Topical analgesic - INDICATIONS & USAGE
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WARNINGS AND PRECAUTIONS
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
- WARNINGS AND PRECAUTIONS
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INDICATIONS & USAGE
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.
- OTHER SAFETY INFORMATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMANIX
simanix pain relieving cream creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69379-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0357 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3 g in 100 g HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 0.035 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69379-013-02 120 g in 1 BOTTLE; Type 0: Not a Combination Product 07/08/2015 07/08/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/08/2015 Labeler - Home Aide Diagnostics, Inc. (783518983) Registrant - Zhejiang Bangli Medical Products Cl. Ltd (421295875) Establishment Name Address ID/FEI Business Operations Zhejiang Bangli Medical Products Co. Ltd 421295875 manufacture(69379-013)
