Label: PROMAST CLEAN ANTISEPTIC HAND AND SKIN SANITIZER POWDERY- alcohol aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 81164-102-01 - Packager: PROMAST KIMYA SANAYI VE TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 26, 2020
If you are a consumer or patient please visit this version.
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- Drug Fact
- Active ingredient
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Warnings
When using this product
• Extremely flammable aerosol. Pressure vessel: May burst if heated.
• Keep away from heat / sparks / flames / hot surfaces. No smoking.
Do not spray towards flame or other sources of fire.
• Vapor and particles of the product could irritate your respiratory organs.
• There are no sights of chronic affects after being exposed to the product.
• There is no known antidote.
• Contact with your doctor immediately in case of poisoning.
• Store the product inside the original packaging.
• Keep it in cool room temperature.
• Do not store with food and oxidizing materials.
- Directions
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INGREDIENTS AND APPEARANCE
PROMAST CLEAN ANTISEPTIC HAND AND SKIN SANITIZER POWDERY
alcohol aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81164-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81164-102-01 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/24/2020 Labeler - PROMAST KIMYA SANAYI VE TICARET ANONIM SIRKETI (505287751) Establishment Name Address ID/FEI Business Operations PROMAST KIMYA SANAYI VE TICARET ANONIM SIRKETI 505287751 manufacture(81164-102)
