HAND SANITIZER- alcohol gel

Hand Sanitizer Citrus Scent by

Drug Labeling and Warnings

Hand Sanitizer Citrus Scent by is a Otc medication manufactured, distributed, or labeled by Clearbrooke Technologies LLC, Clearbrooke Enterprises LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use[s]

• To decrease bacteria on skin that could cause disease
• Recommended for repeated use when soap and water are not available.

Directions

• Wet hands thoroughly with product and allow it to dry without wiping
• For children under 6 years of age use only under adult supervision
• not recommended for infants

Warnings

For external use only: hands.

Flammable. Keep away from heat or flame

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

STOP USE

Stop use and ask a doctor if:

irritation or rash occurs

condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Other information

• Do not store above 105F
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

Glycerin, purified water, Polyacrylamide, C13 - 14 isoparaffin, Laureth-7

Package Label - Principal Display Panel

16 oz NDC: 75366-330-01

32 oz NDC: 75366-330-02

330 gal NDC: 75366-330-03

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75366-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAURETH-7 (UNII: Z95S6G8201)
GLYCERIN (UNII: PDC6A3C0OX)	3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75366-330-01	473.176 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2020
2	NDC: 75366-330-02	946.353 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2020
3	NDC: 75366-330-03	1249190 mL in 1 TANK; Type 0: Not a Combination Product	04/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/23/2020

Labeler - Clearbrooke Technologies LLC (006493200)

Establishment
Name	Address	ID/FEI	Business Operations
Clearbrooke Technologies LLC		006493200	manufacture(75366-330) , label(75366-330) , pack(75366-330)