Label: BIOSILK (alcohol- ethyl alcohol spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 73740-3030-2, 73740-3030-8, 73740-3030-9 - Packager: Farouk Systems, Inc.
- 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 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Dosage & Administration
- Inactive Ingredients
- Active Ingredient
- Keep out of reach of children
- Purpose
- Storage and Handling
-
Warnings
Warnings
For external use only. Flammable. Keep away from heat or flame.Do not use
• in children less than 2 months of age
• on open skin woundsWhen using this product keep out of eyes, ears, and mouth. In case of contact with
eyes, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious
condition.Keep out of reach of children. If swallowed, get medical help or contact Poison Control
Center right away.
- Indications & Usage
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BIOSILK
alcohol (ethyl alcohol) sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73740-3030 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 18.425 g in 100 g HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 1.45 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73740-3030-2 59 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/27/2020 2 NDC:73740-3030-8 237 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/27/2020 3 NDC:73740-3030-9 3785 g in 1 JUG; Type 0: Not a Combination Product 04/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/27/2020 Labeler - Farouk Systems, Inc. (137598132) Registrant - Farouk Systems, Inc. (137598132) Establishment Name Address ID/FEI Business Operations Farouk Systems, Inc. 137598132 manufacture(73740-3030)