Label: PROTECT BY HAND SANITIZER GEL (ETHANOL)- alcohol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 80594-0001-1 - Packager: Ken Company 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 September 14, 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
- INDICATIONS & USAGE
-
WARNINGS
1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and
ears, in the oral cavity (may have irritating effects)
2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.
1) Hypersensitivity symptoms such as rash, erythema, itching, and edema
2) Skin irritation symptoms
3. Other precautions
1) For external use only (do not underwear).
2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the
mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).
4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.
5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.
6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.
7) Do not use for any other purpose.
4. Precautions for storage
1) Avoid shading and keep in shading.
2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.
3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign
Objects. - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROTECT BY HAND SANITIZER GEL (ETHANOL)
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80594-0001 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 LIMONENE, (+)- (UNII: GFD7C86Q1W) TROLAMINE (UNII: 9O3K93S3TK) ROSEMARY OIL (UNII: 8LGU7VM393) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) GLYCERIN (UNII: PDC6A3C0OX) ORANGE OIL (UNII: AKN3KSD11B) CARBOMER 940 (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80594-0001-1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/15/2020 Labeler - Ken Company Co., Ltd. (694883411) Registrant - Ken Company Co., Ltd. (694883411) Establishment Name Address ID/FEI Business Operations Skin n Skin Co., Ltd. 631090037 manufacture(80594-0001) Establishment Name Address ID/FEI Business Operations Ken Company Co., Ltd. 694883411 label(80594-0001)
