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NDC 69394-0004-02 Gel Sanitizer 70 mL/100mL Details

Gel Sanitizer 70 mL/100mL

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

Product Information

NDC	69394-0004
Product ID	69394-004_e4b43c01-0a43-3fe8-e053-2a95a90a33cb
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	Gel Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
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 69394-0004-02 (69394000402)

Pricing Information	N/A
NDC Package Code	69394-004-02
Billing NDC	69394000402
Package	89 mL in 1 BOTTLE, PLASTIC (69394-004-02)
Marketing Start Date	2020-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 34ece294-7ed7-42c3-a29f-9898c64a2509 Details

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on skin.

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.

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

Aloe Vera, Carbomer, D&C Green #5, D&C Yellow #10, Water, Trolamine

Product label

INGREDIENTS AND APPEARANCE

GEL SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69394-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69394-004-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/28/2020
2	NDC:69394-004-02	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/28/2020

Labeler - AAkron Rule Corporation (002434389)

Revised: 7/2022

Document Id: e4b43c01-0a43-3fe8-e053-2a95a90a33cb

Set id: 34ece294-7ed7-42c3-a29f-9898c64a2509

Version: 2

Effective Time: 20220726