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)

PRINCIPAL DISPLAY PANEL - 1064 ML Bottle Label

ANTIBACTERIAL HAND SANITIZER
alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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	07/31/2020
4	NDC:73563-080-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
5	NDC:73563-080-04	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
6	NDC:73563-080-01	29.5 mL in 1 TUBE; Type 0: Not a Combination Product	08/05/2020
7	NDC:73563-080-06	66 mL in 1 TUBE; Type 0: Not a Combination Product	07/20/2020
8	NDC:73563-080-07	7 mL in 1 PACKET; Type 0: Not a Combination Product	05/15/2020
9	NDC:73563-080-12	355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020

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

Labeler - Body One Products , Inc. (117376115)

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

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

Antibacterial Hand Sanitizer