BIOCARE LABS CLEAN HAND SANITIZER- ethyl alcohol 70% v/v gel 
BIOCARE LABS 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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BIOCARE LABS CLEAN HAND SANITIZER

DRUG FACTS

Active Ingredient

Ethyl Alcohol 70% v/v 

Uses:

Hand Sanitizer to help decrease bacteria on the skin.

Warnings:

For external use only.

Flammable. Keep away from heat or flame.

KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use:

near or in the eyes. In case of contact, rinse eyes thoroughly with water.

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: if irritation or redness develop and lasts.

Directions:

• Wet hands thoroughly with product.

• Briskly rub hands together until dry.

• Supervise children under the age of 6 when using this product

Inactive Ingredients:

Deionized Water (Aqua, Eau), Glycerine, Melaleuca Alternafolia (Tea Tree) Leaf Oil,

Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl
Propanol, Acrylates Copolymer, Fragrance (Parfum), Polysorbate-20

Other Information:

• Store at 20°C to 25 °C (68° – 77° F)
• May discolor certain surfaces or fabrics.

For Questions:

Biocare Labs © 2020 Chicago, IL 60469

www.BiocareLabs.com

Clean Hand Sanitizer 2.0 FL OZ

Clean Hand Sanitizer Packet

BIOCARE LABS CLEAN HAND SANITIZER 
ethyl alcohol 70% v/v gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54602-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54602-100-000.060 L in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
2NDC:54602-100-010.0072 L in 1 BLISTER PACK; Type 0: Not a Combination Product04/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/2020
Labeler - BIOCARE LABS INC. (798953493)
Registrant - BIOCARE LABS INC. (798953493)
Establishment
NameAddressID/FEIBusiness Operations
Suraz Corporation Inc.050221596manufacture(54602-100)

Revised: 10/2020
Document Id: 6db5d2b2-7dab-4c53-bd8e-a6e1d623a267
Set id: 7a74262d-9125-4a9b-8e58-81aaca96a91c
Version: 1
Effective Time: 20201005
 
BIOCARE LABS INC.