Aakron Rule Corp - Gel Hand Sanitizer - Coconut Scent

Gel Hand Sanitizer by

Drug Labeling and Warnings

Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Aakron Rule Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GEL HAND SANITIZER COCONUT SCENT- 80% alcohol solution gel 
Aakron Rule Corporation

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.

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Aakron Rule Corp - Gel Hand Sanitizer - Coconut Scent

ACTIVE INGREDIENT

Active Ingredient

Ethyl alcohol 80% v/v

PURPOSE

Purpose

Antiseptic, Hand Sanitizer

USE

Use

Hand sanitizer to decrease bacteria on the skin that could cause disease.

For use when soap and water are not available.

WARNINGS

Warnings

For external use only: hands
Flammable. Keep away from heat or flame.

DO NOT USE

Do not use

on children less than 2 months of age

on open skin wounds

WHEN USING

When using

When using this product keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use

Stop use and ask a doctor if irritation or rash occurs and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DIRECTIONS

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

Other information
Do not store above 115°F

May discolor some fabrics.
May damage wood finishes or plastics.

INACTIVE INGREDIENTS

Inactive ingredients
Fragrance, Glycerin, PEG-6 (and) AMP-acrylates/vinyl isodecanoate crosspolymer, purified water

HAND SANITIZER GEL, COCONUT SCENT, 1 GALLON (3.785 L) - PACKAGE LABEL

AAkron Line - Gel Hand Sanitizer - Coconut Scent - NDC: 69394-003-01

GEL HAND SANITIZER  COCONUT SCENT
80% alcohol solution gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69394-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69394-003-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/08/2021	11/30/2022

Labeler - Aakron Rule Corporation (002434389)

Revised: 11/2022

Document Id: ee4cab0c-3e61-063a-e053-2995a90a7329

34390-5

Set id: badcc5db-4e10-98f6-e053-2995a90a7fbf

Version: 4

Effective Time: 20221125