LOFT AND BEAR HAND WASH 4 OZ. WITH ETHANOL ALCOHOL- alcohol liquid

Loft and Bear Hand Wash 4 oz. with Ethanol Alcohol by

Drug Labeling and Warnings

Loft and Bear Hand Wash 4 oz. with Ethanol Alcohol 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

This is a hand sanitizer. f Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using:

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. Tea Tree Oil (0.125% v/v).
3. Aloe Vera Leaf (0.1% v/v).
4. Lemon Oil (0.0625% v/v).
5. Sterile distilled water or boiled cold water.

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 vera leaf, tea tree oil, lemon oil, purified water USP

Package Label - Principal Display Panel

118.3 mL NDC: 77179-7004-3

INGREDIENTS AND APPEARANCE

LOFT AND BEAR HAND WASH 4 OZ. WITH ETHANOL ALCOHOL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77179-7004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	118.3 mL  in 118.3 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	118.3 mL  in 118.3 mL
LEMON OIL (UNII: I9GRO824LL)	118.3 mL  in 118.3 mL
TEA TREE OIL (UNII: VIF565UC2G)	118.3 mL  in 118.3 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77179-7004-3	118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020

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

Labeler - Y. SA, INC (080269381)

Establishment
Name	Address	ID/FEI	Business Operations
Y. SA, INC		080269381	manufacture(77179-7004)