Label: HANZOL GELLED HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76917-074-01, 76917-074-05, 76917-074-55 - Packager: Plymouth Technology, 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 May 22, 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
Flammable, keep away from fire/flame
For external use only
Do not use
• in children less than 2 months of age
• on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours
- Directions
- Other information
- INACTIVE INGREDIENT
- QUESTIONS
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SPL UNCLASSIFIED SECTION
Alcohol Antiseptic 70%
Topical Solution
Non-Sterile Solution
FLAMMABLE LIQUID
Ground/bond container and receiving equipment.
Use explosion-proof electrical/ventilating/light/equipment.
Use only non-sparking tools.
Take precautionary measures against static discharge.
Do not breathe dust/fume/gas/mist/vapors/spray.
Avoid breathing dust/fume/gas/mist/vapors/spray.
Wash face,hands, and any exposed skin thoroughly after handling.
Do not eat, drink or smoke when using this product.
Use only outdoors or in a well-ventilated area.
Wear protective gloves/protective clothing/eye protection/face protection
IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water [or shower].
IF INHALED:Remove person to fresh air and keep at rest in a position comfortable for breathing.
Store in a well-ventilated place. Keep container tightly closed.
Dispose of contents/container in accordance with local/regional/national/international regulations.
DOT CLASSIFICATION
UN1170, Flammable liquid, n.o.s.(ethanol), 3, II Lot Number:
MADE IN USA
Manufactured by: Plymouth Technology, Inc, 2700 Bond St, Rochester Hills, MI 48309
EMERGENCY TELEPHONE NO.
INFOTRAC (800) 535-5053
www.ptiwater.com
- Packaging
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INGREDIENTS AND APPEARANCE
HANZOL GELLED HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76917-074 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 L in 100 L Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76917-074-01 3.8 L in 1 JUG; Type 0: Not a Combination Product 05/11/2020 2 NDC:76917-074-05 18.9 L in 1 CONTAINER; Type 0: Not a Combination Product 05/11/2020 3 NDC:76917-074-55 208.2 L in 1 DRUM; Type 0: Not a Combination Product 05/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/11/2020 Labeler - Plymouth Technology, Inc. (555926443) Establishment Name Address ID/FEI Business Operations Plymouth Technology, Inc. 555926443 manufacture(76917-074)
