LOFT AND BEAR HAND WASH 4 OZ. WITH ETHANOL ALCOHOL- alcohol liquid 
Y. SA, INC

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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Loft and Bear Hand Wash with Ethanol Alcohol

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

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 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.

Directions

Other information

Inactive ingredients

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

Package Label - Principal Display Panel

118.3 ml label118.3 mL NDC: 77179-7004-3

LOFT AND BEAR HAND WASH 4 OZ. WITH ETHANOL ALCOHOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77179-7004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL118.3 mL  in 118.3 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77179-7004-3118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Y. SA, INC (080269381)
Establishment
NameAddressID/FEIBusiness Operations
Y. SA, INC080269381manufacture(77179-7004)

Revised: 6/2020
Document Id: a79ab91e-7558-f1c1-e053-2995a90a0d57
Set id: a79a960e-2c62-9cdb-e053-2a95a90a4939
Version: 1
Effective Time: 20200608
 
Y. SA, INC