PROSANCA- ethyl 70% aloe vera gel
PROSANCA- isopropyl 70% isopropyl spray
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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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Hand Sanitizer and Rubbing Alcohol

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

Water, Tocophery Acetate, Hydroxythel Urea

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

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.

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

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

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

77838-836 Ethyl 500 ml -91 percent Rubbing Alcohol 77838-636 ISOPROPYL 500 mL- 99 percent Rubbing Alcohol 77838-536 ISOPROPYL 500 ml - 91 percent Rubbing Alcohol 77838-436 ISOPROPYL 500 mL - 70 percent Rubbing Alcohhol 77838-336 Ethyl 70 percent aloe vera Hand Sanitizer 77838-236 Ethyl 70 percent Hand Sanitizer 77838-116 ETHYL 1000 mL - 70 percent Rubbing Alcohol

PROSANCA
ethyl 70% aloe vera gel

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

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
.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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
.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
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

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

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

Labeler - proem group (826841640)

Registrant - proem group (826841640)

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

Revised: 1/2021

Document Id: b65e43dd-9a59-39f0-e053-2a95a90a0ed2

Set id: a67e56ed-ac51-6446-e053-2995a90ac063

Version: 4

Effective Time: 20210104

proem group