Label: FIBERLAY ETHANOL DISPOSABLE GEL DISINFECTANT- 75% ethanolgel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 53048-001-01 - Packager: SHANDONG LUGANGFUYOU MEDICAL 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 May 22, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INDICATIONS & USAGE
1.Hygiene hands: Take an aprpiate amount of hand dsinfectant on the palm of your hands, rub your hands together for 1 minute to dsinfect.
2. Surgical hands: After surgical hand washing take an apropiate amount of hand dsinfecant and evenly apply it to the skin of the hands, forearm and lower third of the upper arm for 3min.
3. Skin: Apply the skin surface evenly for 3min. - ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
1.This is an extemal use dinfectant, please do not take titemallKeep itout of reach of children.
2. This product is fanmmable and away from fre sources.
3. Use with caution to those who are alergic to alcohol.
4. Protect from light and store ina cool, dry, venilatdplace.
5. Avoid couse withantagonist dugs.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIBERLAY ETHANOL DISPOSABLE GEL DISINFECTANT
75% ethanolgel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53048-001 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 375 mL in 500 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor Imprint Code Fiberlay Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53048-001-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/22/2020 Labeler - SHANDONG LUGANGFUYOU MEDICAL CO., LTD (530388354) Establishment Name Address ID/FEI Business Operations SHANDONG LUGANGFUYOU MEDICAL CO., LTD 530388354 manufacture(53048-001)
