Label: HAND SANITIZER 70% GEL- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77042-770-01, 77042-770-08, 77042-770-55 - Packager: Guide Energy Solutions LLC
- Category: HUMAN OTC DRUG LABEL
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 June 16, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient[s]
- Purpose
- Use[s]
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Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
• in children less than 2 months of age
• on open skin wounds
When using this product 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 or rash occurs. These may be signs of a serious condition.
- Directions
- Other information
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
Alcohol Antiseptic 70% Gel
Non-sterile Solution
UN1170
Hazard Class 3
Packing Group II
FLAMMABLE LIQUID
Signal Word: Danger
Proper Shipping Name: Ethanol solution
HAZARD STATEMENTS:
H225 - Highly flammable liquid and vapor.
H319 - Causes serious eye irritation.
H336 – May cause drowsiness or dizzinessPRECAUTION STATEMENTS:
P210 - Keep away from heat/sparks/open flames/hot surfaces. No smoking.
P233 - Keep container tightly closed.
P240 - Ground and bond container and receiving equipment
P241+P242 - Use explosion-proof electrical, ventilating and lighting equipment. Use only non-sparking tools.
P243 - Take precautionary measures against static discharge.
P261 - Avoid breathing fumes, mist and vapor.
P264 - Wash hands and other exposed skin areas thoroughly after handling.
P271 - Use only outdoors or in a well-ventilated area.
P280 - Wear protective gloves/protective clothing/eye protection/face protection.
P303+P361+P353 - IF ON SKIN (or hair): Remove immediately all contaminated clothing. Rinse skin with water or shower.
P304+P340+P312 - IF INHALED: Remove victim to fresh air and keep at rest in a comfortable position for breathing. Call a POISON CENTER or doctor if you feel unwell.
P305+P351+P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P370+P378 - In case of fire: Use water fog, foam, dry chemical or carbon dioxide for extinction.
P405+P403+P233+P235 - Store locked up in a well-ventilated place. Keep container tightly closed. Keep cool.
P501 - Dispose of contents/container to authorized hazardous or special waste collection point in accordance with any local regulation.Guide Energy Solutions, LLC 9330 South Hwy 99 Prague, OK 74864
For Chemical Emergencies: Call Chemtrec at (800) 424-9300. See SDS (Safety Data Sheet) for further information.
- Packaging
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INGREDIENTS AND APPEARANCE
HAND SANITIZER 70% GEL
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77042-770 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 GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) MONOETHANOLAMINE (UNII: 5KV86114PT) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77042-770-01 3.785 L in 1 JUG; Type 0: Not a Combination Product 05/13/2020 2 NDC:77042-770-55 208 L in 1 DRUM; Type 0: Not a Combination Product 05/13/2020 3 NDC:77042-770-08 0.237 L in 1 BOTTLE; Type 0: Not a Combination Product 05/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/13/2020 Labeler - Guide Energy Solutions LLC (117045830)