Label: ELYPTOL ANTIMICROBIAL RUB- ethanol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 69343-221-02, 69343-221-03, 69343-221-08, 69343-221-16, view more69343-221-34 - Packager: Elyptol Inc.
- 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 December 19, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients:
- Purpose
- Keep out reach of children
- Uses
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Warnings
- For external use only
Flammable.
- Keep away from sources of fire or flame.
- If swallowed seek medical advice or contact a Poison Control Center, immediately.
When using this product
- Do not ingest or inhale.
- Keep away from eyes.
- Use undiluted.
Stop using and ask a doctor
- If redness or irritation develops.
- In case of eye contact, rinse eyes with water.
- If issues persist, seek medical attention.
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Directions
• HAND SANITISER/SKIN ANTISEPTIC: Apply Elyptol evenly and rub for 30 seconds.
• SURGICAL HAND DISINFECTION: Apply Elyptol from forearms to fingertips. Rub evenly for 3 minutes, including between fingers and over nails.
• PRE-OPERATIVE SKIN PREPARATION AND SKIN ANTISEPSIS: Apply Elyptol and rub evenly over desired area for 30 seconds. - Other Information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Questions?
- Packaging
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INGREDIENTS AND APPEARANCE
ELYPTOL ANTIMICROBIAL RUB
ethanol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69343-221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 7 mL in 10 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS OIL (UNII: 2R04ONI662) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PIROCTONE OLAMINE (UNII: A4V5C6R9FB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69343-221-02 1 in 1 CARTON 11/01/2014 1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69343-221-03 1 in 1 CARTON 11/01/2014 2 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69343-221-08 1 in 1 CARTON 11/01/2014 3 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:69343-221-16 1 in 1 CARTON 11/01/2014 4 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:69343-221-34 1 in 1 CARTON 11/01/2014 5 1005 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/01/2014 Labeler - Elyptol Inc. (079594781) Establishment Name Address ID/FEI Business Operations 220 Laboratories LLC. 783247950 manufacture(69343-221)