Label: DR.CLEAN- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76850-201-01 - Packager: PH Holdings
- 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 April 25, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient[s]
- Purpose
- Use[s]
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredient[s]
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Precautions for Use
1. If you have any of the following abnormalities using the product,
you must stop using it and as it worsens, please consult a dermatologist, etc.
(While you are using, there are abnormalities such as red spots, swelling,
itching, irritation, etc. and the applied area has the above-mentioned
abnormalities due to direct sunlight)
2. Do not use on areas with wounds or areas with eczema and dermatitis.
3. If it gets into your eyes, wash them immediately with water.
4. Precautions for storage and handling
▷ After use, be sure to close the cap.
▷ Keep out of reach of children.
▷ Do not store in a place with high or low temperature and direct sunlight.
5. This product is not a food / beverage, so do not use it for any purpose
other than its original purpose. If you ingest it, be sure to consult a doctor.
6. Be careful not to get on clothes.
7. Please note that there is a risk of slipping when in contact with the product contents.
- Package Label
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INGREDIENTS AND APPEARANCE
DR.CLEAN
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76850-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 72 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) TROMETHAMINE (UNII: 023C2WHX2V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76850-201-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/10/2020 Labeler - PH Holdings (694838903) Registrant - Geukdong Chemical (689755747) Establishment Name Address ID/FEI Business Operations Geukdong Chemical 689755747 manufacture(76850-201)
