LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 16 OZ- alcohol liquid LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 128 OZ/ 1 GALLON- alcohol liquid LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 8 OZ- alcohol liquid

Loft and Bear Hand Wash with Ethanol Alcohol 8 oz by

Drug Labeling and Warnings

Loft and Bear Hand Wash with Ethanol Alcohol 8 oz by is a Otc medication manufactured, distributed, or labeled by Y. SA, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Sterile distilled water (26.5% v/v).
3. Aloe Barbadensis Leaf liquid (3.2% v/v).
4. Tea Tree Oil (0.3% v/v)

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly 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. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

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.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aloe Barbadensis Leaf liquid, Tea Tree Oil, purified water USP

Package Label - Principal Display Panel

236 mL NDC: 77179-7008-1

473 mL NDC: 77179-7016-2

3785 mL NDC: 77179-7128-4

INGREDIENTS AND APPEARANCE

LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 16 OZ 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77179-7016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	473 mL  in 473 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	473 mL  in 473 mL
TEA TREE OIL (UNII: VIF565UC2G)	473 mL  in 473 mL
WATER (UNII: 059QF0KO0R)	473 mL  in 473 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77179-7016-2	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/12/2020

LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 128 OZ/ 1 GALLON 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77179-7128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	3785 mL  in 3785 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	3785 mL  in 3785 mL
TEA TREE OIL (UNII: VIF565UC2G)	3785 mL  in 3785 mL
WATER (UNII: 059QF0KO0R)	3785 mL  in 3785 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77179-7128-4	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/12/2020

LOFT AND BEAR HAND WASH WITH ETHANOL ALCOHOL 8 OZ 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77179-7008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	236 mL  in 236 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	236 mL  in 236 mL
TEA TREE OIL (UNII: VIF565UC2G)	236 mL  in 236 mL
WATER (UNII: 059QF0KO0R)	236 mL  in 236 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77179-7008-1	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/12/2020

Labeler - Y. SA, INC (080269381)

Establishment
Name	Address	ID/FEI	Business Operations
Y. SA, INC		080269381	manufacture(77179-7008, 77179-7016, 77179-7128)