HIGH PURITY HAND SANITIZER- alcohol gel 
High Purity Natural 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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Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

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

Other information

Inactive ingredients

DI Water, Vegetable Glycerin, Carbomer (ultrez 10), Diisopropylamine, Lemon Essential Oil

Package Label - Principal Display Panel

60 mL NDC: 75061-065-00

60mL Hand Sanitizer

HIGH PURITY HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75061-065
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
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO) 0.133 mL  in 100 mL
LEMON OIL, DISTILLED (UNII: ET5GD00TRP) 0.15 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.274 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75061-065-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2020
Labeler - High Purity Natural Products LLC (114392832)
Establishment
NameAddressID/FEIBusiness Operations
High Purity Natural Products LLC114392832manufacture(75061-065)

Revised: 7/2020
Document Id: a9efda4f-a777-51e6-e053-2a95a90abe1a
Set id: a9efca92-1e46-1808-e053-2995a90abc31
Version: 1
Effective Time: 20200708
 
High Purity Natural Products LLC