Label: GURTLER RX HAND SANITIZER- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54555-132-01, 54555-132-02, 54555-132-03, 54555-132-04 - Packager: Brainerd Chemical Company 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 July 1, 2020
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient[s]
- Purpose
- Use[s]
- Warnings
- Directions
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - 3.785 L Jug Label
GURTLER
INDUSTRIES, INC.GURTLER Rx HAND SANITIZER
DANGER
HAZARD STATEMENTS
Highly flammable liquid and vapor.
Causes serious eye irritation.
May cause drowsiness or dizziness.PRECAUTIONARY STATEMENTS
Keep away from heat/sparks/open flames/hot surfaces. - No smoking. Keep container
tightly closed. Ground/bond container and receiving equipment. Use explosion-proof
electrical/ventilating/lighting equipment. Use only non-sparking tools.Take precautionary measures against static discharge. Avoid breathing dust/fume/gas/
mist/vapors/spray. Wear protective gloves/protective clothing/eye protection/face
protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical
advice/attention. In case of fire: Use dry sand/dry chemical/alcohol-resistant foam for
extinction. Store in a well-ventilated place. Keep cool. Store locked up. Dispose of
contents/container to an approved waste disposal facility.UN1987, ALCOHOLS, N.O.S. (Isopropyl Alcohol), 3, PG III, LIMITED QUANTITY
!
UN1987PRODUCT CODE
NET CONTENTS
PACK INFO
LOT NUMBERGurtler Industries, Inc.
15475 S. LaSalle St.
South Holland, IL 60473
1-800-638-7300NATIONAL POISON CONTROL CENTER 1-800-222-1222
FOR ADDITIONAL INFORMATION SEE SDS
For Spill Emergencies 24 hour Call Chemtrec 1-800-424-9300MADE IN U.S.A.
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INGREDIENTS AND APPEARANCE
GURTLER RX HAND SANITIZER
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54555-132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) alcohol 750 mL in 1 L Inactive Ingredients Ingredient Name Strength Cocamidopropyl Betaine (UNII: 5OCF3O11KX) hydrogen peroxide (UNII: BBX060AN9V) water (UNII: 059QF0KO0R) LIMONENE OXIDE, TRANS-(+)- (UNII: 8VUQ1B30IK) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54555-132-04 1040.9 L in 1 TANK; Type 0: Not a Combination Product 07/01/2020 2 NDC:54555-132-03 208.1 L in 1 DRUM; Type 0: Not a Combination Product 07/01/2020 3 NDC:54555-132-02 18.9 L in 1 JUG; Type 0: Not a Combination Product 07/01/2020 4 NDC:54555-132-01 3.785 L in 1 JUG; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 07/01/2020 Labeler - Brainerd Chemical Company Inc., (787442417) Establishment Name Address ID/FEI Business Operations Brainerd Chemical Company Inc., 787442417 MANUFACTURE(54555-132) , LABEL(54555-132) , PACK(54555-132) , REPACK(54555-132)