GEL HAND SANITIZER- alcohol gel 
5 Peaks Products, 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.

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70% Gel Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To help reduce bacteria on skin.

Warnings

For external use only. Flammable, keep away from source of heat & fire.

When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use & ask doctor if irritation occurs or redness develops & persists.

Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.

Directions

Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.

Inactive ingredients

Water (Aqua, Eau), Glycerin, Liquid Preneutralized Thickener/Emulsifier, Squalane, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Tocopheryl Acetate.

Package Label - Principal Display Panel

5 Peaks 3.4oz Tube5 Peaks 8.45 oz Bottle5 Peaks 16.9 oz Bottle5 Peaks 1 Liter Bottle5 Peaks 1 Gallon Bottle5 Peaks 55 Gallon Drum5 Peaks 1000 L IBC Tote

100 mL NDC: 80242-100-01

250 mL NDC: 80242-100-02

500 mL NDC: 80242-100-03

1 L NDC: 80242-100-04

3.785 L NDC: 80242-100-05

208 L NDC: 80242-100-06

1000 L NDC: 80242-100-07

iUnderstand Product Label

iUnderstand 8.45 oz bottleiUnderstand 16.9 oz bottleiUnderstand 1 Liter Bottle

250 mL NDC: 80242-100-02

500 mL NDC: 80242-100-03

1 L NDC: 80242-100-04

GEL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80242-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
SQUALANE (UNII: GW89575KF9)  
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80242-100-01100 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2020
2NDC:80242-100-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
3NDC:80242-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
4NDC:80242-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
5NDC:80242-100-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
6NDC:80242-100-06208000 mL in 1 DRUM; Type 0: Not a Combination Product09/01/2020
7NDC:80242-100-071000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - 5 Peaks Products, LLC (117631506)
Registrant - 5 Peaks Products, LLC (117631506)

Revised: 9/2020
Document Id: af252c98-af6a-2be5-e053-2995a90a76db
Set id: af2530a9-92a2-0b43-e053-2995a90ae8c5
Version: 1
Effective Time: 20200912
 
5 Peaks Products, LLC