Bare Hands by Coola, LLC / EC Labs / Natures Formulae Health Products Ltd. Coola - Bare Hands

Bare Hands by

Drug Labeling and Warnings

Bare Hands by is a Otc medication manufactured, distributed, or labeled by Coola, LLC, EC Labs, Natures Formulae Health Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BARE HANDS- ethyl alcohol 70% lotion 
Coola, LLC

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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Coola - Bare Hands

Drug facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Ethyl Alcohol 70%.........Antiseptic

Uses

- to help reduce bacteria on skin. - for repeated use.

Warnings

Flammable. Keep away from fire/flame.

For external use only.

Whe using this product: avoid contact with eyes. · in case of eye contact, immediately flush eyes with water, call a doctor. · Avoid contact with broken skin.

Discontinue use if irritation or redness develops. If condition persists for than 72 hours, consult a doctor.

Keep out of reach of children. Children should only use this product under adult supervision. Do not drink. Not edible. In case of accidental ingestion seek professional assistance or contact a Poison Control Center right away.

Directions

· Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. · Recommended for repeated use.

Other Information

· Do not store abot 104F (40C) · May discolor some fabrics · Harmful to wood finishes and plastics.

Inactive Ingredients

Allyl Heptoate, Benzyl Alcohol, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Gamma-Decalactone, Gamme-Nonalactone, Gamme-Octalactone, Glycerin, Heliotopine, Polyacrylate Crosspolymer-6, Raspberry Ketone, Sodium Hydroxide, Triethyl Citrate, Vanillin, Water

BARE HANDS 
ethyl alcohol 70% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
.GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
PIPERONAL (UNII: KE109YAK00)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VANILLIN (UNII: CHI530446X)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
ALLYL HEPTANOATE (UNII: AU4CYG9V68)
.GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-001-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/04/2020	12/31/2022

Labeler - Coola, LLC (956990290)

Registrant - Coola, LLC (956990290)

Establishment
Name	Address	ID/FEI	Business Operations
EC Labs		205510751	manufacture(79753-001)

Establishment
Name	Address	ID/FEI	Business Operations
Natures Formulae Health Products Ltd.		241385587	manufacture(79753-001)

Revised: 12/2022

Document Id: f0ff41cc-42d7-ed95-e053-2a95a90a7828

34390-5

Set id: ae82f3c5-d295-4f20-e053-2a95a90a0f1e

Version: 2

Effective Time: 20221229

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