STAYCLEAN MOISTURIZING HAND GEL SANITIZER 2OZ- alcohol gel STAYCLEAN MOISTURIZING HAND GEL SANITIZER 3.8L- alcohol gel STAYCLEAN MOISTURIZING HAND GEL SANITIZER 8OZ- alcohol gel
Stayclean Moisturizing Hand Gel Sanitizer 8OZ by
Drug Labeling and Warnings
Stayclean Moisturizing Hand Gel Sanitizer 8OZ by is a Otc medication manufactured, distributed, or labeled by Canterbury Clean, LLC, Nu-World Corporation. 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:
- 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
- Package Label - Principal Display Panel-3.8L
- Package Label .Principal Display Panel-8oz
- Packag label.Principal Display Panel-2OZ
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INGREDIENTS AND APPEARANCE
STAYCLEAN MOISTURIZING HAND GEL SANITIZER 2OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 77711-003 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 GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.65597 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 BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 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: 77711-003-00 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/19/2020 STAYCLEAN MOISTURIZING HAND GEL SANITIZER 3.8L
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 77711-001 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 GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.65597 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 BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 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: 77711-001-00 3800 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/19/2020 STAYCLEAN MOISTURIZING HAND GEL SANITIZER 8OZ
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 77711-002 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 GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL in 100 mL WATER (UNII: 059QF0KO0R) 27.65597 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 BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0098 mL in 100 mL ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.001 mL in 100 mL ETHOHEXADIOL (UNII: M9JGK7U88V) 0.00015 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: 77711-002-00 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/19/2020 Labeler - Canterbury Clean, LLC (117521212) Registrant - Nu-World Corporation (628045858) Establishment Name Address ID/FEI Business Operations Nu-World Corporation 628045858 manufacture(77711-001, 77711-002, 77711-003)
236ml, NDC: 
59ml, NDC: © 2024 FDA.report
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