PROSANCA- ethyl 70% aloe vera gel PROSANCA- ethanol alcohol gel PROSANCA- isopropyl 70% isopropyl spray PROSANCA- isopropyl 91% isopropyl spray PROSANCA- ethanol 91% ethanol applicator spray PROSANCA- 70% ethanol spray PROSANCA- isopropyl 99% isopropyl spray

Prosanca by

Drug Labeling and Warnings

Prosanca by is a Otc medication manufactured, distributed, or labeled by proem group, HAI THANH V.N PRODUCTION TRADING CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

70% Ethanal, 91% Ethanol, 70% Isopropyl, 91% Isopropyl, 99% Isopropyl.

INACTIVE INGREDIENT

Water, Tocophery Acetate, Hydroxythel Urea

WARNINGS

For external use only, Flammable, Keep away from heat or flam.

Do not use: in children less 2 months of age on open skin wounds

When use this product: this product keep out of eyes,ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs, these may be signs of s serious condition

Keep out of reach of children. If swallow get medical or contact of poison Control Center right away

INDICATIONS & USAGE

Hand Sanitizer to help reduce bateria that potentially can cause disease for use when soap are not available.

Rubbing Alocohol keep out of eyes, ears and mouth. Incase of contact with eyes rinse thorough with water.

KEEP OUT OF REACH OF CHILDREN

If swallow, get medical help or contact o poison control Center right away.

DOSAGE & ADMINISTRATION

70% Ethanol alcohol, 91% Ethanol Alcohol, 70% Isopropyl, 91% Isopropyl, 99% Isopropyl

PURPOSE

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap are not avalble.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROSANCA 
ethyl 70% aloe vera gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77838-336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.145 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	FRUIT (Aloe Vera)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77838-336-06	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
2	NDC: 77838-336-07	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
3	NDC: 77838-336-08	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
4	NDC: 77838-336-09	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
5	NDC: 77838-336-10	3875 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2021

PROSANCA 
ethanol alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77838-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77838-236-01	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
2	NDC: 77838-236-02	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
3	NDC: 77838-236-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
4	NDC: 77838-236-04	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021
5	NDC: 77838-236-05	3875 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2021

PROSANCA 
isopropyl 70% isopropyl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77838-436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHANETHIOIC ACID, S-(1-((1E)-2-HYDROXYETHENYL)BUTYL) ESTER (UNII: ZTU0NID6V5)	0.145 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.145 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77838-436-11	500 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/15/2021
2	NDC: 77838-436-12	1000 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2021

PROSANCA 
isopropyl 91% isopropyl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77838-536
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	91 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.145 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ETHANETHIOIC ACID, S-(1-((1E)-2-HYDROXYETHENYL)BUTYL) ESTER (UNII: ZTU0NID6V5)	0.145 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77838-536-13	500 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2021

PROSANCA 
ethanol 91% ethanol applicator spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77838-836
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	91 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.145 mL  in 100 mL
ETHANETHIOIC ACID, S-(1-((1E)-2-HYDROXYETHENYL)BUTYL) ESTER (UNII: ZTU0NID6V5)	0.145 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77838-836-17	500 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/15/2021
2	NDC: 77838-836-18	1000 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2021

PROSANCA 
70% ethanol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77838-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHANETHIOIC ACID, S-(1-((1E)-2-HYDROXYETHENYL)BUTYL) ESTER (UNII: ZTU0NID6V5)	0.145 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.145 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77838-116-15	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2021
2	NDC: 77838-116-16	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2021

PROSANCA 
isopropyl 99% isopropyl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77838-636
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	99 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.145 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ETHANETHIOIC ACID, S-(1-((1E)-2-HYDROXYETHENYL)BUTYL) ESTER (UNII: ZTU0NID6V5)	0.145 mL  in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77838-636-14	500 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/15/2021

Labeler - proem group (826841640)

Registrant - proem group (826841640)

Establishment
Name	Address	ID/FEI	Business Operations
HAI THANH V.N PRODUCTION TRADING CO., LTD		555256561	manufacture(77838-116, 77838-336, 77838-436, 77838-536, 77838-636, 77838-836, 77838-236)