INSANITIZE- hand sanitizer liquid

InSanitize by

Drug Labeling and Warnings

InSanitize by is a Otc medication manufactured, distributed, or labeled by JOKER AG, Guangzhou Berfly Cosmetic Co., Ltd. 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) (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. Water
3. Carbomer Homopolymer
4. Glycerin
5. Aloe Vera Leaf
6. Propylene Glycol
7. Tert-butyl alcohol
8. Denatonium benzoate
9. Triisopropanolamine
10. 3,5,5-TRIMETHYLHEXANAL

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)

Alcohol 72% 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

Water
Carbomer Homopolymer
Glycerin
Aloe Vera Leaf
Propylene Glycol
Tert-butyl alcohol
Denatonium benzoate
Triisopropanolamine
3,5,5-TRIMETHYLHEXANAL

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSANITIZE 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75757-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
3,5,5-TRIMETHYLHEXANAL (UNII: U62H30BXPJ)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75757-301-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 75757-301-02	43 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 75757-301-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 75757-301-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 75757-301-05	220 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 75757-301-06	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 75757-301-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 75757-301-08	995 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 75757-301-09	1890 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 75757-301-10	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC: 75757-301-11	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC: 75757-301-12	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC: 75757-301-13	15000 mL in 1 BOTTLE; 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 - JOKER AG (480850932)

Establishment
Name	Address	ID/FEI	Business Operations
JOKER AG		480850932	manufacture(75757-301)