SOFRESH HAND SANITIZER ULTRA GEL 01- alcohol hand sanitizer liquid

SoFresh Hand Sanitizer Ultra Gel by

Drug Labeling and Warnings

SoFresh Hand Sanitizer Ultra Gel by is a Otc medication manufactured, distributed, or labeled by Qualitary Inc, SHANTOU S.E.Z BAOJIE INDUSTRY 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. 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.
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.

Active Ingredient(s)

Ethyl 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

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, water, PEG 10 Hydrogenated Castor Oil, Carbomer, Tocopherol, Isopropyl Myristate, Aloe Vera Leaf, Fragrance (Parfum)

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SOFRESH HAND SANITIZER ULTRA GEL  01
alcohol hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78544-101
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	21.925 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.5 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.1 mL  in 100 mL
PEG-10 HYDROGENATED CASTOR OIL (UNII: MH590ECD4O)	0.5 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.05 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.05 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78544-101-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2020
2	NDC: 78544-101-01	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2020
3	NDC: 78544-101-03	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2020

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

Labeler - Qualitary Inc (117526752)

Registrant - Qualitary Inc (117526752)

Establishment
Name	Address	ID/FEI	Business Operations
Qualitary Inc		117526752	relabel(78544-101)

Establishment
Name	Address	ID/FEI	Business Operations
SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD		546345856	manufacture(78544-101)