Label: ANIOSGEL 85 NPC- alcohol gel
- NDC Code(s): 62169-203-12, 62169-203-17
- Packager: Laboratoires Anios
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- INDICATIONS & USAGE
Indications & Usage:
HYDROALCOHOLIC ANTISEPTIC GEL FOR SKIN AND HANDSClose
- INSTRUCTIONS FOR USE
Instructions for Use/Directions
Hygienic Treatment: Apply 3 ml of gel to cupped palm of hands. Rub fingertips and hands thoroughly until completely dry, for at least 30 seconds.
Surgical disinfection: 2 x 3 ml for a hand rubbing time of 2 x 45 seconds.
• Do not rinseClose
- WARNINGS AND PRECAUTIONS
Warnings and Precautions
For external use only
• Do not swallow
• Keep away from heat source
• If accidental eye contact occurs, rinse thoroughly with water
• If irritation persists, consult a physician
ln case of ingestion, get medical help or contact a Poison Control Center right away.Close
• Hygienic treatmentClose
• Surgical disinfection
- INACTIVE INGREDIENT
Inert ingredients 30.0% (w/w)Close
For Warnings, please refer to "WARNINGS AND PRECAUTIONS SECTION"Close
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ANIOSGEL 85 NPC
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62169-203 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 377.5 mL in 500 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) 122.5 mL in 500 mL Product Characteristics Color Score Shape FREEFORM Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62169-203-12 12 in 1 PACKAGE 1 NDC:62169-203-17 500 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/01/2014 Labeler - Laboratoires Anios (274758465) Establishment Name Address ID/FEI Business Operations Laboratoires Anios 274758465 manufacture(62169-203)