Label: BIO HAND SANITIZER GE L- ethanol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 80642-020-01 - Packager: Seoul Food Research & Development Co., Ltd.
- 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 October 23, 2020
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
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WARNINGS
For external use only
Flammable. Keep away from heat and flame.When using this product ■ Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ Avoid contact with broken skin. ■ Do not inhale or ingest.
Stop use and ask a doctor if skin irritation or rash develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIO HAND SANITIZER GE L
ethanol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80642-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 375 mL in 500 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80642-020-01 500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2020 Labeler - Seoul Food Research & Development Co., Ltd. (688787758) Registrant - Seoul Food Research & Development Co., Ltd. (688787758) Establishment Name Address ID/FEI Business Operations Seoul Food Research & Development Co., Ltd. 688787758 manufacture(80642-020)