Sanify by Ripshot Enterprises / Lusty Libation Ltd. SANIFY- alcohol gel

Sanify by

Drug Labeling and Warnings

Sanify by is a Otc medication manufactured, distributed, or labeled by Ripshot Enterprises, Lusty Libation Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation).

1. Alcohol (ethanol) (71.35%, 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 (0.8648% v/v).
3. Hydrogen peroxide (0.1081% v/v).
4. Hydroxyethyl cellulose
5. Sterile distilled water or boiled cold water.

The alcohol utilized in this formulation is consistent with the recommendations outlined in the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry

Active Ingredient(s)

Alcohol 80% 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

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

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

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,Hydroxyethyl cellulose

Package Label - Principal Display Panel

118mL NDC: 78586-558-04

236mL NDC: 78586-558-08

500mL NDC: 78586-558-69

1000mL NDC: 78586-558-10

INGREDIENTS AND APPEARANCE

SANIFY 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78586-558
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71.351 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)	0.7027 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.8648 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.1081 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	27.027 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78586-558-04	118.294 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/01/2020
2	NDC: 78586-558-08	236.588 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/01/2020
3	NDC: 78586-558-10	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/01/2020
4	NDC: 78586-558-69	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020

Labeler - Ripshot Enterprises (241994209)

Registrant - Ripshot Enterprises (241994209)

Establishment
Name	Address	ID/FEI	Business Operations
Lusty Libation Ltd.		203992437	manufacture(78586-558)