Label: LIDOCAINE HCL 4% ointment
- NDC Code(s): 63868-451-72
- Packager: CHAIN DRUG MARKETING ASSOCIATION INC
- 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.
Updated April 12, 2022
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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 carton, do not allow contact with the eyes, do not bandage or apply local heat (such as heating pads) to the area of use.
Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
LIDOCAINE HCL 4%
lidocaine hcl 4% ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-451 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 Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-451-72 76.5 g in 1 BOTTLE; Type 0: Not a Combination Product 10/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/28/2020 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)