Label: ZOVACIL 5- lidocaine hydrochloride cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82067-100-60 - Packager: EUROTAS PHARMACEUTICALS, 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 June 29, 2022
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- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Avoid contact with eyes
Do not exceed the recommended daily dosage unless director by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using a finger or any medical device or applicator.
Stop use and ask doctor if
• Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use.
Keep out of reach of children
• If a product is swallowed, get medical help or contact a Poison Control Center right away. - KEEP OUT OF REACH OF CHILDREN
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Directions
For adults, when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product.
Apply externally to the affected area not more than 6 times daily. Children under 12 years of age: consult a physician. -
Inactive Ingredients
Aqua (Deionized Water), Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Isoprpoyl Palmitate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine
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INGREDIENTS AND APPEARANCE
ZOVACIL 5
lidocaine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82067-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CHONDROITIN 6-SULFATE (UNII: 7LWQ6472SP) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) EMU OIL (UNII: 344821WD61) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) LAURETH-7 (UNII: Z95S6G8201) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82067-100-60 60 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2022 Labeler - EUROTAS PHARMACEUTICALS, LLC (118129083)
