Label: LIDOCAINE HCL 4% MENTHOL 1% ointment
- NDC Code(s): 69729-452-72
- Packager: OPMX 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 10, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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WARNINGS
For external use only
Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor.
When using this product use only as directed. Read and follow all directions and warnings on this label, rare cases of serious burns have been reported with products of this type, do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days.
Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE HCL 4% MENTHOL 1%
lidocaine hcl 4% menthol 1% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-452 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-452-72 76.6 g in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/2020 Labeler - OPMX LLC (029918743)
