Label: SANITIZE 75- hand sanitizer gel
SANITIZE NT-75- hand sanitizer gel
SANITIZE NT-80- hand sanitizer gel
SANITIZE 80- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76747-0180-1, 76747-0180-2, 76747-0180-3, 76747-0275-1, view more76747-0275-2, 76747-0275-3, 76747-0380-1, 76747-0380-2, 76747-0380-3, 76747-0475-1, 76747-0475-2, 76747-0475-3 - Packager: Manufacturers Chemicals
- 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 September 2, 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:
Sanitize 80
- Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (0.725% v/v).
- Copolymer (6 % v/v).
- Trolamine (0.3 % v/v).
- FD&C Blue No.1 (0.00018 % 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.
Sanitize NT-80
a. Ethanol (80%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
b. Glycerol (0.725% v/v).
c. Hydroxyethyl Cellulose (1.8 % v/v).d. Trolamine (0.3 v/v).
e. FD&C Blue No.1 (0.00018 % v/v).
e. 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.
Sanitize 75
a. 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.
b. Glycerol (0.725 % v/v).
c. Copolymer (8.2 % v/v).
d. Trolamine (1 % v/v)
e. FD&C Blue No.1 (0.00018 % v/v).
f. 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.
Sanitize NT-75
a. 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.
b. Glycerol (0.725% v/v).
c. Hydroxyethyl Cellulose (1.8 % v/v).d. Trolamine (0.3 v/v).
e. FD&C Blue No.1 (0.00018 % v/v).
e. 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
SANITIZE 75
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76747-0275 Route of Administration 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 BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) 8.2 mL in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 1 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76747-0275-1 204412 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2020 2 NDC:76747-0275-2 1022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 03/30/2020 3 NDC:76747-0275-3 18921 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 SANITIZE NT-75
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76747-0475 Route of Administration 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL in 100 mL WATER (UNII: 059QF0KO0R) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 1.8 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76747-0475-1 204412 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2020 2 NDC:76747-0475-2 1022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 03/30/2020 3 NDC:76747-0475-3 18921 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 SANITIZE NT-80
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76747-0380 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL in 100 mL WATER (UNII: 059QF0KO0R) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 1.8 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76747-0380-1 204412 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2020 2 NDC:76747-0380-2 1022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 03/30/2020 3 NDC:76747-0380-3 18921 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 SANITIZE 80
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76747-0180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00018 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.8 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.725 mL in 100 mL WATER (UNII: 059QF0KO0R) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) 6 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76747-0180-1 204412 mL in 1 DRUM; Type 0: Not a Combination Product 03/30/2020 2 NDC:76747-0180-2 1022000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 03/30/2020 3 NDC:76747-0180-3 18921 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Manufacturers Chemicals (968260323) Establishment Name Address ID/FEI Business Operations Manufacturers Chemicals 968260323 manufacture(76747-0275, 76747-0475, 76747-0380, 76747-0180)