HUSH HAND SANITIZER WITH ALOE VERA EXTRACT- alcohol gel

Hush hand sanitizer with aloe vera extract by

Drug Labeling and Warnings

Hush hand sanitizer with aloe vera extract by is a Otc medication manufactured, distributed, or labeled by Hush Cosmetic Products SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Acohol, 70% v/v

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Recommended for repeated use.

Warnings

Flammable. Keep away from heat or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

• Place enough product on hands to cover all surfaces. 
• Rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110 0F (43 0C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Aloe Vera Extract, Carbomero, Glycerin, Fragance (Parfum), Purified Water (Aqua), Triethanolamine

Package Label - Principal Display Panel

45 mL Label

60 mL Label

120 mL Label

240 mL Label

500 mL label

INGREDIENTS AND APPEARANCE

HUSH HAND SANITIZER WITH ALOE VERA EXTRACT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78442-001
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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78442-001-01	45 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78442-001-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
3	NDC: 78442-001-03	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
4	NDC: 78442-001-04	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
5	NDC: 78442-001-05	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
6	NDC: 78442-001-06	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
7	NDC: 78442-001-07	3780 mL in 1 PACKAGE; Type 0: Not a Combination Product	08/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Hush Cosmetic Products SRL (816367113)

Establishment
Name	Address	ID/FEI	Business Operations
Hush Cosmetic Products SRL		816367113	manufacture(78442-001)