Gel Antibacterial Alcohol: Package Insert and Label Information

GEL ANTIBACTERIAL ALCOHOL- alcohol gel
Sanchez, S.a. De C.v.

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.

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) (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.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. 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.

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

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 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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label — Principal Display Panel

GEL ANTIBACTERIAL ALCOHOL gel antibacterial alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78316-002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 75 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN TROLAMINE WATER FRAGRANCE LAVENDER & CHIA F-153480 ALOE VERA LEAF LAVENDER OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78316-002-01 200000 mL in 1 BOTTLE, PLASTIC None 2 NDC:78316-002-02 1000 mL in 1 BOTTLE, PLASTIC None 3 NDC:78316-002-03 500 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020

Labeler — Sanchez, S.a. De C.v. (810011809)

Registrant — Sanchez, S.a. De C.v. (810011809)

Establishment
Name	Address	ID/FEI	Operations
Sanchez, S.a. De C.v.		810011809	manufacture (78316-002)

Revised: 06/2020 Sanchez, S.a. De C.v.