Label: MULTI-PURPOSE SANITIZING AND CLEANSING ALCOHOL WIPES- alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 55549-010-50, 55549-010-60, 55549-010-80 - Packager: Southern Chem Industries 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 September 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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 occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center immediately
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
MULTI-PURPOSE SANITIZING AND CLEANSING ALCOHOL WIPES
alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55549-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55549-010-80 400 mL in 1 CANISTER; Type 0: Not a Combination Product 03/30/2020 2 NDC:55549-010-60 800 mL in 1 CANISTER; Type 0: Not a Combination Product 03/30/2020 3 NDC:55549-010-50 2500 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Southern Chem Industries LLC (056025778) Registrant - Southern Chem Industries LLC (056025778) Establishment Name Address ID/FEI Business Operations Southern Chem Industries LLC 056025778 manufacture(55549-010)