OTC Medication Information: Hand Sanitizer Mist

HAND SANITIZER MIST- alcohol spray
GTG WELLNESS CO., LTD.

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.

ACTIVE INGREDIENT

Alcohol 70% w/w

INACTIVE INGREDIENTS

Water, Glycerin, Fragrance, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Sophora Angustifolia Root Extract

PURPOSE

SANITIZER

WARNINGS

• Flammable. Keep away from heat and flame.
• For external use only.
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Do not use
• on children less than 2 months old, or on open skin wounds.

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When using this product • avoid contact with eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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, seek medical help or contact a Poison Control Center right away at (800) 222-1222.

Uses

■ to help reduce bacteria on skin.

Directions

■ Place enough sanitizer on hands to cover all surfaces.
■ Rub hands until dry.
■ Children should be supervised when using this product to avoid swallowing .

Other information

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

Questions

• FCO Genesis I, Inc

• www.fcogen1.com

• 1-888-970-7617

71080-0022-1: Hand Sanitizer Mist (Bucks)

71080-0022-2: Hand Sanitizer Mist (Bulls)

71080-0022-3: Hand Sanitizer Mist (Celtics)

71080-0022-4: Hand Sanitizer Mist (Clippers)

71080-0022-5: Hand Sanitizer Mist (Golden State Warriors)

HAND SANITIZER MIST alcohol spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71080-0022 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (ALCOHOL) Alcohol 11.9 g in 17 mL

Inactive Ingredients Ingredient Name Strength Water Glycerin GREEN TEA LEAF GRAPEFRUIT SOPHORA FLAVESCENS ROOT

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71080-0022-1 17 mL in 1 CARTON None 2 NDC:71080-0022-2 17 mL in 1 CARTON None 3 NDC:71080-0022-3 17 mL in 1 CARTON None 4 NDC:71080-0022-4 17 mL in 1 CARTON None 5 NDC:71080-0022-5 17 mL in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/10/2021

Labeler — GTG WELLNESS CO., LTD. (689458057)

Registrant — GTG WELLNESS CO., LTD. (689458057)

Establishment
Name	Address	ID/FEI	Operations
Natural Korea Co., Ltd.		688729438	manufacture (71080-0022)

Revised: 05/2021 GTG WELLNESS CO., LTD.