Label: LACTONE CARVACROL HAND DISINFECTANT- ethyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 75348-560-15 - Packager: ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI
- 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 May 28, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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 wounds
When 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.
- Directions:
- Other Information:
- Inactive ingredients:
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
LACTONE CARVACROL HAND DISINFECTANT
ethyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75348-560 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength BUTANE (UNII: 6LV4FOR43R) ISOBUTANE (UNII: BXR49TP611) PROPANE (UNII: T75W9911L6) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L) THYME OIL (UNII: 2UK410MY6B) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75348-560-15 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/22/2020 Labeler - ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI (519983719) Establishment Name Address ID/FEI Business Operations ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI 519983719 manufacture(75348-560)