G SOL SANITIZING- silver spray

G SOL Sanitizing by

Drug Labeling and Warnings

G SOL Sanitizing by is a Otc medication manufactured, distributed, or labeled by GP&E Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

G SOL SANITIZING 
silver spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81042-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Silver (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G)	Silver	0.005 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Titanium Dioxide (UNII: 15FIX9V2JP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Polysorbate 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81042-010-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/01/2020

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	Business Operations
GP&E Co., Ltd.		689816478	manufacture(81042-010)