Label: LIDOCAINE 5% ointment
- NDC Code(s): 0363-4530-19
- Packager: WALGREENS CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 15, 2020
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
Children under 12 years: consult a doctor
To use finger cots: Roll one finger cot over finger. Gently squeeze cream over affected area.
- INDICATIONS & USAGE
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WARNINGS
For external use only
When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, symptoms clear up and return within a few days.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE 5%
lidocaine 5% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4530 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 HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) WATER (UNII: 059QF0KO0R) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-4530-19 28.3 g in 1 PACKAGE; Type 0: Not a Combination Product 01/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 01/15/2019 Labeler - WALGREENS CO. (008965063)
