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Hand Sanitizer Cristal Prime 100ml by
Drug Labeling and Warnings
Hand Sanitizer Cristal Prime 100ml by is a Otc medication manufactured, distributed, or labeled by YELLOW USA CORP, KG INCORPORATING EMPREENDIMENTOS E SERVICOS EIRELI, KERALUX INDUSTRIA E COMERCIO DE COSMETICOS LTDA. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using 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 a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER CRISTAL PRIME 100 LITERS
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-135 Route of Administration EXTRACORPOREAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 L in 100 L HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L in 100 L WATER (UNII: 059QF0KO0R) 28 L in 100 L CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 L in 100 L ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-135-81 100 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 25000 LITERS
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-138 Route of Administration EXTRACORPOREAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 L in 100 L HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L in 100 L WATER (UNII: 059QF0KO0R) 28 L in 100 L CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 L in 100 L ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-138-95 25000 L in 1 TANK; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 1000 LITERS
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-137 Route of Administration EXTRACORPOREAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 L in 100 L HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L in 100 L WATER (UNII: 059QF0KO0R) 28 L in 100 L CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 L in 100 L ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-137-91 1000 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 250ML
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-130 Route of Administration TOPICAL, EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-130-25 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 220 LITERS
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-136 Route of Administration EXTRACORPOREAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 L in 100 L Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 L in 100 L HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L in 100 L WATER (UNII: 059QF0KO0R) 28 L in 100 L CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 L in 100 L ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-136-82 220 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 60ML
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-128 Route of Administration TOPICAL, EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-128-06 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 500ML
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-131 Route of Administration TOPICAL, EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-131-50 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 1 LITER
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-132 Route of Administration TOPICAL, EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-132-71 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 5 LITERS
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-134 Route of Administration EXTRACORPOREAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-134-75 5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 30ML
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-127 Route of Administration TOPICAL, EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-127-03 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 1 GALON
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-133 Route of Administration EXTRACORPOREAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-133-73 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 HAND SANITIZER CRISTAL PRIME 100ML
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 79445-129 Route of Administration EXTRACORPOREAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL in 100 mL WATER (UNII: 059QF0KO0R) 28 mL in 100 mL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) 0.35 mL in 100 mL ISOPROPANOLAMINE (UNII: UE40BY1BZW) 0.27 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 79445-129-10 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - YELLOW USA CORP (008925051) Registrant - KG INCORPORATING EMPREENDIMENTOS E SERVICOS EIRELI (945091407) Establishment Name Address ID/FEI Business Operations YELLOW USA CORP 008925051 repack(79445-127, 79445-128, 79445-129, 79445-130, 79445-131, 79445-132, 79445-133, 79445-134, 79445-135, 79445-136, 79445-137, 79445-138) Establishment Name Address ID/FEI Business Operations KERALUX INDUSTRIA E COMERCIO DE COSMETICOS LTDA 900345228 manufacture(79445-127, 79445-128, 79445-129, 79445-130, 79445-131, 79445-132, 79445-133, 79445-134, 79445-135, 79445-136, 79445-137, 79445-138)
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