Label: SCHOOL HEALTH HAND SANITIZER- alcohol gel
- NDC Code(s): 75594-090-01, 75594-090-02, 75594-090-03, 75594-090-04
- Packager: Commercial Beverage Concepts, LLC
- This is a repackaged label.
- Source NDC Code(s): 74221-003
- 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.
Updated July 27, 2020
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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)
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
SCHOOL HEALTH HAND SANITIZER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75594-090(NDC:74221-003) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 L in 1 L Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75594-090-02 0.437 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/28/2020 2 NDC:75594-090-03 0.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/28/2020 3 NDC:75594-090-04 3.785 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/28/2020 4 NDC:75594-090-01 0.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/28/2020 Labeler - Commercial Beverage Concepts, LLC (080925174) Establishment Name Address ID/FEI Business Operations Commercial Beverage Concepts, LLC 080925174 pack(75594-090) , label(75594-090) , relabel(75594-090) , repack(75594-090)