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NDC 69394-0001-02 Hand Sanitizer 80 mL/100mL Details

Hand Sanitizer 80 mL/100mL

Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AAkron Rule Corporation. The primary component is ALCOHOL.

Product Information

NDC	69394-0001
Product ID	69394-001_e4a2adc1-fcf5-895a-e053-2a95a90ac09b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	AAkron Rule Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69394-0001-02 (69394000102)

Pricing Information	N/A
NDC Package Code	69394-001-02
Billing NDC	69394000102
Package	89 mL in 1 BOTTLE, PLASTIC (69394-001-02)
Marketing Start Date	2020-08-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7ff1c2d4-3a11-4606-829e-0c8930d7c3e2 Details

Active Ingredient

Alcohol 80% v/v.

Purpose

Antiseptic

Use(S)

helps reduce bacteria that can cause disease when soap and water are not available.

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 avoid mouth, eyes, and ears. In case of contact with eyes, flush with water .

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help and call Poison Control.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age.

Other information

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

Inactive ingredients

Glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER

alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69394-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69394-001-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020
2	NDC:69394-001-02	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020
3	NDC:69394-001-03	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/04/2020

Labeler - AAkron Rule Corporation (002434389)

Revised: 7/2022

Document Id: e4a2adc1-fcf5-895a-e053-2a95a90ac09b

Set id: 7ff1c2d4-3a11-4606-829e-0c8930d7c3e2

Version: 4

Effective Time: 20220725