ANTIBACTERIAL HAND SANITIZER- alcohol gel

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Body One Products , Inc., BMC 1092, Inc. dba Solo Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on the skin
• recommended for repeated use.

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use in the eyes. In case of contact, rinse eyes with water.

Stop use and ask a doctor if irritation and redness develop and presist for more than 72 hours.

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

Directions

• wet hands thoroughly with product
• briskly rub hands together until dry
• supervise children in the use of this product

Other information

• store at 20° to 20°C (68 to 77° F)
• may discolor certain fabrics

Inactive ingredients

Water, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,PEG 60 Almond Glycerides, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate,Triisopropanolamine, Fragrance

PRINCIPAL DISPLAY PANEL - 1064 ML Bottle Label

BodyOne
Products

ANTIBACTERIAL
HAND SANITIZER

kills 99.99%
of all germs

(32 FL.OZ. 1064ML)

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73563-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Propylene Glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73563-080-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2020
2	NDC: 73563-080-18	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2020
3	NDC: 73563-080-32	1064 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	03/10/2020

Labeler - Body One Products , Inc. (117376115)

Registrant - BMC 1092, Inc. dba Solo Laboratories, Inc. (078831987)

Establishment
Name	Address	ID/FEI	Business Operations
BMC 1092, Inc. dba Solo Laboratories, Inc.		078831987	MANUFACTURE(73563-080) , LABEL(73563-080) , PACK(73563-080)