Label: LIDOCAINE cream
- NDC Code(s): 75834-141-30
- Packager: Nivagen Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
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Updated October 13, 2023
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
For external use only.
When using this product
- avoid contact with eyes
- do not use in large quantities, particularly over large surfaces or blistered areas
- 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
- When practical, cleanse 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.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75834-141 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CHOLESTEROL (UNII: 97C5T2UQ7J) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TOCOPHEROL (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75834-141-30 30 g in 1 TUBE; Type 0: Not a Combination Product 12/15/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/15/2016 Labeler - Nivagen Pharmaceuticals, Inc. (052032418) Registrant - Westwood Laboratories, LLC (832280635)