Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 77838-116-15, 77838-116-16, 77838-236-01, 77838-236-02, view more77838-236-03, 77838-236-04, 77838-236-05, 77838-336-06, 77838-336-07, 77838-336-08, 77838-336-09, 77838-336-10, 77838-436-11, 77838-436-12, 77838-536-13, 77838-636-14, 77838-836-17, 77838-836-18 - Packager: proem group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROSANCAÂ
ethyl 70% aloe vera gelProduct 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 PROSANCAÂ
ethanol alcohol gelProduct 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 PROSANCAÂ
isopropyl 70% isopropyl sprayProduct 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 PROSANCAÂ
isopropyl 91% isopropyl sprayProduct 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 PROSANCAÂ
ethanol 91% ethanol applicator sprayProduct 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 PROSANCAÂ
70% ethanol sprayProduct 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 PROSANCAÂ
isopropyl 99% isopropyl sprayProduct 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 -Â proem group (826841640) Registrant -Â 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)
