HK Instant Hand Sanitizer

HK Instant Hand Sanitizer by

Drug Labeling and Warnings

HK Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Auto-Chlor System. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HK INSTANT HAND SANITIZER- ethanol gel 
Auto-Chlor System

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.

----------

HK Instant Hand Sanitizer

Ethyl alcohol 62%v/v

Antiseptic

Hand sanitizer to reduce microorganisms on the skin. Use this product when soap and water are not available.

Flammable. Keep away from fire or flame.

For external use only.

When using this product, do not use around or near the eyes. If contact occurs, flush eyes with water and contact a doctor immediately.

Stop use and consult a doctor when skin irritation appears and lasts.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Directions

Place a palmful (5 grams) of product in one hand.

Spread on both hands and rub into skin until dry (1-2 minutes)

Place a smaller amount (2.5 grams) into one hand and spread over both hands and wrists.

Rub into skin until dry.

Water, polyethylene glycol, glycerin, acrylate polymer, fragrance, polyoxyethylene glyceryl monococoate

L10233 293 20

L10233 293 20

HK INSTANT HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68604-233
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
FRAGRANCE MINT ORC2000774 (UNII: G7LK3FFB99)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68604-233-02	4 in 1 BOX	10/29/2020
1	NDC: 68604-233-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/29/2020	12/30/2022

Labeler - Auto-Chlor System (965194330)

Establishment
Name	Address	ID/FEI	Business Operations
Auto-Chlor System		965194330	manufacture(68604-233)

Revised: 12/2022

Document Id: f10ced33-635c-51ee-e053-2995a90a857b

34390-5

Set id: b2d1840a-64da-0617-e053-2a95a90abef5

Version: 3

Effective Time: 20221230