Label: STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 8 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 2 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 2 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 8 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 8 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 8 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 2 FL.OZ- alcohol gel
STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 2 FL.OZ- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77711-004-00, 77711-005-00, 77711-006-00, 77711-007-00, view more77711-008-00, 77711-009-00, 77711-010-00, 77711-011-00 - Packager: Canterbury Clean, LLC
- 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 August 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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-Blue Berry 2 FL.OZ
- Inactive Ingredient-Blue Berry 8 FL.OZ
- Inactive Ingredient-Watermelon 2 FL.OZ
- Inactive Ingredient-Watermelon 8 FL.OZ
- Inactive Ingredeint-Lemon Citrus 2 FL.OZ
- Inactive Ingredient-Lemon Citrus 8 FL.OZ
- Inactive Ingredient-Coconut 2 FL.OZ
- Inactive ingredeint-Coconut 8 FL.OZ
- Package Label - Principal Display Panel-Blue Berry 2 FL.OZ
- Package Label. Principal Display Panel-Blueberry 8 FL.OZ
- Package Label. Principal Display Panel-Watermelon 2 FL.OZ
- Package Label. Principal Display Panel-Watermelon 8 FL.OZ
- Package Label. Principal Display Panel-Lemon Citrus 2 FL.OZ
- Package Label. Principal Display Panel-Lemon Citrus 8 FL.OZ
- Package Label. Principal Display Panel-Coconut 2 FL.OZ
- Package Label. Principal Display Panel-Coconut 8 FL.OZ
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INGREDIENTS AND APPEARANCE
STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 8 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00352 mL in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 0.0095 mL in 100 mL BENZYL CINNAMATE (UNII: V67O3RO97U) 0.00122 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL LOWBUSH BLUEBERRY (UNII: G90PX41VP0) 0.0005 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44597 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL BENZYL BENZOATE (UNII: N863NB338G) 0.10132 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 0.01306 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-005-00 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 2 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00005 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.013294 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0135 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44597 mL in 100 mL EUGENOL (UNII: 3T8H1794QW) 0.0011988 mL in 100 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00002 mL in 100 mL COCONUT WATER (UNII: 267F5Y81NT) 0.00628 mL in 100 mL COCONUT JUICE (UNII: AMN6S4M09G) 0.00015 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-010-00 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 STAYCLEAN SCENTED HAND GEL SANITIZER BLUEBERRY 2 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00352 mL in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 0.0095 mL in 100 mL BENZYL CINNAMATE (UNII: V67O3RO97U) 0.00122 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL LOWBUSH BLUEBERRY (UNII: G90PX41VP0) 0.0005 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44597 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL BENZYL BENZOATE (UNII: N863NB338G) 0.10132 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 0.01306 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-004-00 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 STAYCLEAN SCENTED HAND GEL SANITIZER COCONUT 8 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00005 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.013294 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0135 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44597 mL in 100 mL EUGENOL (UNII: 3T8H1794QW) 0.0011988 mL in 100 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00002 mL in 100 mL COCONUT WATER (UNII: 267F5Y81NT) 0.00628 mL in 100 mL COCONUT JUICE (UNII: AMN6S4M09G) 0.00015 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-011-00 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 8 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 0.003967 mL in 100 mL WATERMELON (UNII: 231473QB6R) 0.002 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0178 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0064532 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44597 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) 0.0002 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-007-00 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 8 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength CITRAL (UNII: T7EU0O9VPP) 0.01092882 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.07050642 mL in 100 mL LEMON PEEL (UNII: 72O054U628) 0.002 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44497 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01018 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL ETHYLHEXYL PALMITATE (UNII: 2865993309) 0.008 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL BASIL OIL (UNII: Z129UMU8LE) 0.00099636 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-009-00 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 STAYCLEAN SCENTED HAND GEL SANITIZER LEMON CITRUS 2 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength CITRAL (UNII: T7EU0O9VPP) 0.01092882 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.07050642 mL in 100 mL LEMON PEEL (UNII: 72O054U628) 0.002 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44497 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.01018 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL ETHYLHEXYL PALMITATE (UNII: 2865993309) 0.008 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL BASIL OIL (UNII: Z129UMU8LE) 0.00099636 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-008-00 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 STAYCLEAN SCENTED HAND GEL SANITIZER WATERMELON 2 FL.OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77711-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 0.003967 mL in 100 mL WATERMELON (UNII: 231473QB6R) 0.002 mL in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.25 mL in 100 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.06303 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0178 mL in 100 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0064532 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.44597 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) 0.0002 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.00005 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77711-006-00 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/29/2020 Labeler - Canterbury Clean, LLC (117521212) Registrant - Nu-World Corporation (628045858) Establishment Name Address ID/FEI Business Operations Nu-World Corporation 628045858 manufacture(77711-005, 77711-004, 77711-006, 77711-007, 77711-008, 77711-009, 77711-010, 77711-011)
59 mL NDC: 77711-004-00
236ml NDC:77711-005-00
59ml NDC: 77711-006-00
59ml NDC:77711-008-00
236ml NDC:77711-009-00
59 ml, NDC:77711-010-00
236ml NDC:77711-011-00