Label: ALCOHOL HAND WIPES- ethyl alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 90083-211-12, 90083-211-20, 90083-211-50 - Packager: OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI
- Category: HUMAN OTC DRUG LABEL
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 September 6, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - Stop Use
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Storage
- Inactive ingredients
- Inactive Ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ALCOHOL HAND WIPES
ethyl alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:90083-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 3.059 mL in 4.37 mL Inactive Ingredients Ingredient Name Strength PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) EDETIC ACID (UNII: 9G34HU7RV0) POLYSORBATE 20 (UNII: 7T1F30V5YH) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DEXPANTHENOL (UNII: 1O6C93RI7Z) GLYCERIN (UNII: PDC6A3C0OX) LEMON OIL, DISTILLED (UNII: ET5GD00TRP) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:90083-211-50 2185 mL in 1 CANISTER; Type 0: Not a Combination Product 09/07/2020 2 NDC:90083-211-20 874 mL in 1 CANISTER; Type 0: Not a Combination Product 09/07/2020 3 NDC:90083-211-12 524.4 mL in 1 CANISTER; Type 0: Not a Combination Product 09/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/07/2020 Labeler - OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI (595865355) Registrant - Huzeyfe Islamoglu (595865355) Establishment Name Address ID/FEI Business Operations OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI 595865355 manufacture(90083-211)