Label: KEEP IT KLEEN- ethanol alcohol sd gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 77568-123-45 - Packager: LIQUID LABS LLC
- 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 February 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- OTC - Purpose
- Indications and Usage
- Warnings
-
Purpose
Uses (s)
Purpose: Antiseptic
Use(s) Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water not available.
USE ONLY AS DIRECTED
Do not use: in children less than 2 months of age
on open skin wounds
to inject, inhale, or ingest
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.
Stop and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep our of reach of children. If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222
Directions
* Place enought product on hands to cover all surfaces.
Rub hands together until dry.
*Supervise children under 6 years of age when using this product to avoid swallowing
- Dosage & Administration
-
USE ONLY AS DIRECTED
USE ONLY AS DIRECTED
Do not use: in children less than 2 months of age
on open skin wounds
to inject, inhale, or ingest
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.
Stop and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep our of reach of children. If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222
Directions
* Place enought product on hands to cover all surfaces.
Rub hands together until dry.
*Supervise children under 6 years of age when using this product to avoid swallowing
- OTC - Keep Out of Reach of Children
- Other Information
- Inactive Ingredients
- Principal Label. Principal Display Panel
-
INGREDIENTS AND APPEARANCE
KEEP IT KLEEN
ethanol alcohol sd gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77568-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 70 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size 120000mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77568-123-45 1 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/03/2022 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/03/2022 Labeler - LIQUID LABS LLC (080287020) Registrant - LIQUID LABS LLC (080287020) Establishment Name Address ID/FEI Business Operations Goodwin Co. 806987483 manufacture(77568-123)