HAND SANITIZER- hand sanitizer spray
Ningbo Venus Cosmetic Co., Ltd.

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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14341-006
HAND SANITIZER

Active Ingredient(s)

0.3% Benzalkonium chloride

Purpose

Use when needed.

DIRECTIONS

Spray hand sanitizer in the palm of your hands.
Rub briskly product onto hands and allow to dry.

Warnings

For external use only. Avoid contact with eyes. If contact occurs, flush eyes with water. If the condition persists, consult a doctor.
If swallowed immediately call a poison control center or a doctor for treatment advice.

Do not use

For external use only. Avoid contact with eyes. If contact occurs, flush eyes with water. If the condition persists, consult a doctor.

If swallowed immediately call a poison control center or a doctor for treatment advice.

Directions

Spray hand sanitizer in the palm of your hands.
Rub briskly product onto hands and allow to dry.

Other information

Store at temperatures below 30°C.

Inactive ingredients

Water, Glycerine, Decyl Glucoside, Aloe Vera, Fructooligosaccharide, Fragrance

Package Label - Principal Display Panel

250 400 100

HAND SANITIZER
hand sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14341-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.01 mL in 100 mL
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	0.01 mL in 100 mL
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.01 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14341-006-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
2	NDC:14341-006-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
3	NDC:14341-006-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020
4	NDC:14341-006-04	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/20/2020

Labeler - Ningbo Venus Cosmetic Co., Ltd. (421364944)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Venus Cosmetic Co., Ltd.		421364944	manufacture(14341-006)

14341-006 HAND SANITIZER