Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol gel
Marquis Extraction Technology LLC

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.

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteriaon the skin that potentially can cause disease. For use when soap and water are unavailable

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
  • in eyes

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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

acrylates copolymer, alpha tocopherol acetate, Denatonium benzoate, glycerin, isopropyl myristate propylene glycol, triisopropyl amine, fragrance

Package Label — Principal Display Panel

NDC 76585-004
(click image for full-size original)

HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76585-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S) 5 mL in 100 mL
ALPHA-TOCOPHEROL 0.005 mL in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 0.6 mL in 100 mL
GLYCERIN 1.25 mL in 100 mL
ISOPROPYL MYRISTATE 0.2 mL in 100 mL
WATER
PROPYLENE GLYCOL 0.75 mL in 100 mL
TRIISOPROPYLAMINE 0.875 mL in 100 mL
CUMINYL ACETALDEHYDE 0.6 mL in 100 mL
LINALOOL, (+)- 0.6 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76585-004-17 3785 mL in 1 BOTTLE None
2 NDC:76585-004-11 473 mL in 1 BOTTLE None
3 NDC:76585-004-13 236 mL in 1 BOTTLE None
4 NDC:76585-004-14 946 mL in 1 BOTTLE None
5 NDC:76585-004-12 1040875 mL in 1 BOTTLE None
6 NDC:76585-004-18 355 mL in 1 BOTTLE None
7 NDC:76585-004-15 12113 mL in 1 BOTTLE None
8 NDC:76585-004-16 18927 mL in 1 BOTTLE None
9 NDC:76585-004-20 59 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/27/2020
Labeler — Marquis Extraction Technology LLC (117496233)
Establishment
Name Address ID/FEI Operations
Marquis Extraction Technology LLC 117496233 manufacture (76585-004)

Revised: 06/2020 Marquis Extraction Technology LLC

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