SOFRESH HAND SANITIZER ULTRA GEL 01- alcohol hand sanitizer liquid 
Qualitary Inc

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.

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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

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

Other information

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

SoFresh Hand Sanitizer Ultra Gel 33.8 OzSoFresh Hand Sanitizer Ultra Gel 16.9 OzSoFresh Hand Sanitizer Ultra Gel 8 Oz

SOFRESH HAND SANITIZER ULTRA GEL  01
alcohol hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78544-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78544-101-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
2NDC:78544-101-01237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
3NDC:78544-101-031000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2020
Labeler - Qualitary Inc (117526752)
Registrant - Qualitary Inc (117526752)
Establishment
NameAddressID/FEIBusiness Operations
Qualitary Inc117526752relabel(78544-101)
Establishment
NameAddressID/FEIBusiness Operations
SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD546345856manufacture(78544-101)

Revised: 9/2020
Document Id: ae6f26c1-6fdc-df08-e053-2a95a90a55c9
Set id: a721cce0-d9e1-e295-e053-2995a90a5012
Version: 2
Effective Time: 20200903
 
Qualitary Inc