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Hand Sanitizer by Hot Focus, Inc.

Medically reviewed on December 13, 2017

Dosage form: gel
Ingredients: BENZALKONIUM CHLORIDE 0.13g in 1mL
Labeler: Hot Focus, Inc.
NDC Code: 70096-001

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.

Hand Sanitizer

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

Purpose

Antiseptic

Use

Decreases bacteria on hands

Warning

For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

KEEP OUT OF REACH OF CHILDREN.

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

Stop use and ask a doctor

if irritation or rash appears on the skin.

DIRECTIONS
  • Rub dime sized amount between hands until dry.
  • Supervise children in the use of this product.

OTHER INFORMATION

Store below 105 F

Inactive Ingredients

Deionizer Water, Glycerin, Silicone Oil, Aloe Barbadensis Leaf Extract, Propylene Glycol, Kathon, EDTA-2NA, Tocopherol Acetate, Fragrance.

Package Label

HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70096-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.13 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
ALOE VERA LEAF 
PROPYLENE GLYCOL 
4,5-DICHLORO-2-OCTYL-3-ISOTHIAZOLONE 
EDETIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:70096-001-3030 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/15/2015
Labeler - Hot Focus, Inc. (197910404)
Establishment
NameAddressID/FEIOperations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(70096-001)
Establishment
NameAddressID/FEIOperations
Yuyao Jessie Commodity Co., Ltd529892305manufacture(70096-001)

 
Hot Focus, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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