HAND SANITIZER- alcohol aerosol, spray

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Aloe Barbadenis Leaf Juice.
3. Caprylyl Glycol.
4. Glycerin.
5. Phenoxyethanol.
6. Polysorate-20.
7. Purified Water.
8. Tocopheryl Acetate.

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

SD Alcohol 40 75%

PURPOSE

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame. For external use only.

WHEN USING

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughtly with water.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center right away.

Directions

• Use enough product in your palm to cover hands and rub hands together biskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110F (43C)
• May discolor fabrics or surfaces

Inactive ingredients

Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Fragrance, Glycerin, Phenoxyethanol, Polysorbate-20, Purified Water, Tocopheryl Acetate.

Package Label - Principal Display Panel

NDC: 58133-959-66

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-959
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-959-66	178 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package	08/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/30/2021

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-959) , label(58133-959) , pack(58133-959) , analysis(58133-959)