Label: ZYLOTROL- lidocaine hcl 4%, menthol 1% gel
- NDC Code(s): 76420-145-04
- Packager: Asclemed USA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 81902-201
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ZYLOTROL
lidocaine hcl 4%, menthol 1% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76420-145(NDC:81902-201) 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, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOPROPYL ALCOHOL (UNII: ND2M416302) PHENOXYETHANOL (UNII: HIE492ZZ3T) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76420-145-04 1 in 1 BOX 06/12/2022 1 118.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 06/12/2022 Labeler - Asclemed USA, Inc. (059888437) Establishment Name Address ID/FEI Business Operations ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel(76420-145)