Label: ALCOHOL HAND WIPES- ethyl alcohol cloth
-
Contains inactivated NDC Code(s)
NDC Code(s): 78141-211-12, 78141-211-20, 78141-211-50 - Packager: Fuson LLC
- 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 August 21, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Inactive Ingredients
- Purpose
- Use
- Warnings
- Do Not Use
- When Using
- Stop Use
- KEEP OUT OF REACH OF CHILDREN
- Dierctions
- Storage
- Package Label
-
INGREDIENTS AND APPEARANCE
ALCOHOL HAND WIPES
ethyl alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78141-211 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 DEXPANTHENOL (UNII: 1O6C93RI7Z) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) EDETIC ACID (UNII: 9G34HU7RV0) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LEMON OIL, DISTILLED (UNII: ET5GD00TRP) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78141-211-50 2185 mL in 1 CANISTER; Type 0: Not a Combination Product 09/16/2020 2 NDC:78141-211-20 874 mL in 1 CANISTER; Type 0: Not a Combination Product 09/16/2020 3 NDC:78141-211-12 524.4 mL in 1 CANISTER; Type 0: Not a Combination Product 09/16/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/16/2020 Labeler - Fuson LLC (113376279) Registrant - OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI (595865355)