Label: AG LINEA HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77781-001-01, 77781-001-03, 77781-001-04 - Packager: Natural Dyes Inc
- 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 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only: hands.
Flammable. Keep away from fire or flame.
When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.
Stop use and ask a doctor if • redness or irritation develop
• condition persists for more than 72 hours
- Directions
- Other information
- Inactive ingredients:
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SPL UNCLASSIFIED SECTION
Distributed by:
Natural Dyes Inc.
New York, NY 10018
Made in China
UPC CODE
Kills 99.9% of Germs
ADVANCED MOISTURIZING FORMULA WITH ALOE AND VITAMIN E
HOW TO USE HAND SANITIZER
Dispense a coin sized drop of sanitizer on your palm.
Spread the sanitizer and rub palms together.
Rub sanitizer on palms, between fingers, finger tips, and back of hands.
Rub hands together for 20 seconds until sanitizer dries.
- Packaging
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INGREDIENTS AND APPEARANCE
AG LINEA HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77781-001 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 WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77781-001-04 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2020 2 NDC:77781-001-01 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2020 3 NDC:77781-001-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/30/2020 Labeler - Natural Dyes Inc (078772235) Establishment Name Address ID/FEI Business Operations Taizhou Huangyan Liweir Cosmetic Technology LTD 560781517 manufacture(77781-001) Establishment Name Address ID/FEI Business Operations Sanrace Biotechnology Co., Ltd. 543000938 manufacture(77781-001)
