Label: ZYLOTROL PAIN RELIEVING- lidocaine hcl, menthol cream
- NDC Code(s): 76420-560-04
- Packager: Asclemed USA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 81902-230
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
Ask a doctor before use if you have a heart condition.
Do not use •if you are allergic to any other type of numbing medicine •in large quantities, particularly over raw surfaces or blistered areas •on infections •on deep puncture wounds •if pregnant or breastfeeding.
When using this product •do not use over large skin areas •do not apply heat, bandages or plastic wrap to treated areas •do not use in or near the eyes •wash hands immediately after using.
Stop use and ask a doctor if •allergic reaction occurs •condition worsens or does not improve within 7 days •symptoms clear up and return within a few days •redness, irritation, swelling, pain or other symptoms begin or increase.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients:
Allantoin, Aloe Barbadensis Leaf Juice*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana Flower Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calophyllum Inophyllum (Tamanu) Seed Oil, Caprylic/capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Ethylhexylglycerin, Hypericum Perforatum (St. John's Wort) Flower/leaf/stem Extract, Glyceryl Stearate, Glycerin, Hydrogenated Polydecene, Isopropyl Palmitate, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate 60, Propanediol, Sodium Polyacrylate, Stearyl Alcohol, Tetrahydroxypropyl Ethylenediamine, Trideceth-6, Water.
*Certified Organic Ingredient - Mayacert Certifier
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INGREDIENTS AND APPEARANCE
ZYLOTROL PAIN RELIEVING
lidocaine hcl, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76420-560(NDC:81902-230) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) SHEA BUTTER (UNII: K49155WL9Y) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DOCOSANOL (UNII: 9G1OE216XY) EDETOL (UNII: Q4R969U9FR) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ALLANTOIN (UNII: 344S277G0Z) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) AVOCADO OIL (UNII: 6VNO72PFC1) TAMANU OIL (UNII: JT3LVK84A1) POLYSORBATE 60 (UNII: CAL22UVI4M) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CHAMOMILE (UNII: FGL3685T2X) ST. JOHN'S WORT (UNII: UFH8805FKA) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) TRIDECETH-6 (UNII: 3T5PCR2H0C) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76420-560-04 102 g in 1 TUBE; Type 0: Not a Combination Product 05/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 12/29/2022 Labeler - Asclemed USA, Inc. (059888437) Establishment Name Address ID/FEI Business Operations ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel(76420-560)
