PROSERA SOOTHING HAND SANITIZING WIPES- alcohol cloth

Prosera Soothing Hand Sanitizing wipes by

Drug Labeling and Warnings

Prosera Soothing Hand Sanitizing wipes by is a Otc medication manufactured, distributed, or labeled by D-Time Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol 80% v/v. 

Purpose

Antiseptic skin cleanser

Uses

For personal hand hygiene to help prevent the spread of bacteria.

Warnings

For external use only. 
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop use and consult a healthcare professional if irritation develops.

Flammability warning: Flammable. Keep away from open flame and sources of heat.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 2 years. For occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Other information

• Store at 68-70  0F (20-25 0C)
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water (Aqua), Isopropyl alcohol, Glycerin, Hyaluronic acid, Allantoin, Vitamin E, Vetiver Oil, Sage Oil, Hydrogen peroxide

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

PROSERA SOOTHING HAND SANITIZING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75306-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VETIVER OIL (UNII: 9M9P32M01L)
SAGE OIL (UNII: U27K0H1H2O)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75306-011-01	1 in 1 POUCH	06/01/2020
1		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 75306-011-02	10 in 1 POUCH	06/01/2020
2		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 75306-011-03	20 in 1 POUCH	06/01/2020
3		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 75306-011-04	50 in 1 POUCH	06/01/2020
4		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 75306-011-05	100 in 1 POUCH	06/01/2020
5		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 75306-011-06	250 in 1 POUCH	06/01/2020
6		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 75306-011-07	50 in 1 CONTAINER	06/01/2020
7		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 75306-011-08	100 in 1 CONTAINER	06/01/2020
8		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 75306-011-09	250 in 1 CONTAINER	06/01/2020
9		2 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - D-Time Limited Liability Company (081728006)