Label: LOFT AND BEAR HAND WASH 4 OZ. WITH ETHANOL ALCOHOL- alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77179-7004-3 - Packager: Y. SA, INC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated June 8, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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:
- 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.
- Tea Tree Oil (0.125% v/v).
- Aloe Vera Leaf (0.1% v/v).
- Lemon Oil (0.0625% v/v).
- Sterile distilled water or boiled cold water.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
LOFT AND BEAR HAND WASH 4 OZ. WITH ETHANOL ALCOHOL
alcohol liquidProduct 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)