Label: CURIST LIDOCAINE NUMBING RELIEF- lidocaine cream
- NDC Code(s): 72559-012-08, 72559-012-15
- Packager: Little Pharma, Inc.
- 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.
Updated July 25, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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.
DOSAGE & ADMINISTRATION
- When practical, clean the affected 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 of age: consult a doctor.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
CURIST LIDOCAINE NUMBING RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72559-012 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) CARBOMER 940 (UNII: 4Q93RCW27E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZYL ALCOHOL (UNII: LKG8494WBH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TROLAMINE (UNII: 9O3K93S3TK) Product Characteristics Color white (White to Off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72559-012-08 170 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2021 2 NDC:72559-012-15 1 in 1 CARTON 11/30/2021 01/20/2022 2 170 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 final part346 04/14/2021 Labeler - Little Pharma, Inc. (074328189)