HAND SANITIZER- benzalkonium chloride gel
Hot Focus, Inc.

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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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

Front

Back1 Back2 Back3

HAND SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70096-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
4,5-DICHLORO-2-OCTYL-3-ISOTHIAZOLONE (UNII: HCY9Q844W2)
EDETIC ACID (UNII: 9G34HU7RV0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70096-001-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2015	12/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/15/2015	12/16/2018

Labeler - Hot Focus, Inc. (197910404)

Name	Address	ID/FEI	Business Operations
Establishment
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(70096-001)

Name	Address	ID/FEI	Business Operations
Establishment
Yuyao Jessie Commodity Co., Ltd		529892305	manufacture(70096-001)

Revised: 2/2019

Document Id: 82f8334a-7884-a77a-e053-2991aa0a5636

Set id: c86f37a0-a288-45c2-aaa3-57b116676a18

Version: 4

Effective Time: 20190228

Hot Focus, Inc.