Label: BIOTECH DISINFECTANT HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77791-002-01, 77791-002-02, 77791-002-03, 77791-002-04, view more77791-002-05, 77791-002-06, 77791-002-07, 77791-002-08 - Packager: BIOTECH INDUSTRIES
- 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 May 16, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only.
Flammable. Keep away from heat or flame
When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.
Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
BIOTECH DISINFECTANT HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77791-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77791-002-01 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2020 2 NDC:77791-002-02 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2020 3 NDC:77791-002-03 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2020 4 NDC:77791-002-04 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2020 5 NDC:77791-002-05 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2020 6 NDC:77791-002-06 18927 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/03/2020 7 NDC:77791-002-07 208198 mL in 1 DRUM; Type 0: Not a Combination Product 05/03/2020 8 NDC:77791-002-08 946353 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/03/2020 Labeler - BIOTECH INDUSTRIES (040897538) Establishment Name Address ID/FEI Business Operations BIOTECH INDUSTRIES 040897538 manufacture(77791-002)
