Label: GIO SOLUTION SANITIZER- ethanol synthetic alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76532-040-01 - Packager: GREEN WONIL CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 2, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
For external use only. Flammable. Keep away from heat or flame
When using this product
if following abnormal symptoms persist, discontinue use. lrritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes
Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis 2) Skin lrritation 3) Following instructions when using medication (1) For external use only (Do not use internally) (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.
Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin. It is not recommended to use this one areas that have been medically treated with a cast or bandage.
Do not use in combination with soap or antibacterial cleansing agents. - KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other Information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GIO SOLUTION SANITIZER
ethanol synthetic alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76532-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) AminomethylPropanol (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76532-040-01 60 mL in 1 CARTON; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/01/2020 Labeler - GREEN WONIL CO., LTD. (688442099) Registrant - GREEN WONIL CO., LTD. (688442099) Establishment Name Address ID/FEI Business Operations GREEN WONIL CO., LTD. 688442099 manufacture(76532-040)
