Label: CELLAPY DR SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69278-110-01, 69278-110-02 - Packager: GM Holdings Co., Ltd
- Category: HUMAN OTC DRUG LABEL
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 March 20, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- Uses:
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WARNINGS
Warnings
For external use only
When using this product if following abnormal symptoms persist, discontinue use
1) Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashesStop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
a) For external use only (Do not use internally)
b) Avoid getting into the eyes
(if contact occurs, wash well with clean water)
Be careful to not 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 may occur or sickness 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.
Precautions
1) Keep out of open flames
2) Keep out of reach of children
3) Do not replace the container with another as quality deterioration or accidents may occur - Directions
- PACKAGE LABEL - 70mL Tube
- PACKAGE LABEL - 500mL Bottle Pump
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INGREDIENTS AND APPEARANCE
CELLAPY DR SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69278-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70.0 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69278-110-01 70 mL in 1 TUBE; Type 0: Not a Combination Product 03/04/2020 2 NDC:69278-110-02 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/04/2020 Labeler - GM Holdings Co., Ltd (688439958) Registrant - GM Holdings Co., Ltd (688439958) Establishment Name Address ID/FEI Business Operations Korea Life Science Co.,ltd 694914835 manufacture(69278-110)