G SOL Sanitizing: Package Insert and Label Information

G SOL SANITIZING- silver spray
GP&E Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Silver 0.005%

INACTIVE INGREDIENTS

Water, Titanium Dioxide, Citric Acid, Polysorbate 20

PURPOSE

Sanitizer

WARNINGS

For external use only.
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of 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.
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Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Use(s)

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

• Spray 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)
• Avoid direct sunlight and tightly

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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G SOL SANITIZING
silver spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81042-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Silver (SILVER) Silver 0.005 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Titanium Dioxide
CITRIC ACID MONOHYDRATE
Polysorbate 20
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81042-010-01 100 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2020
Labeler — GP&E Co., Ltd. (689816478)
Registrant — GP&E Co., Ltd. (689816478)
Establishment
Name Address ID/FEI Operations
GP&E Co., Ltd. 689816478 manufacture (81042-010)

Revised: 09/2022 GP&E Co., Ltd.

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