Label: LIDOCAINE cream
- NDC Code(s): 58980-824-30
- Packager: Stratus Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 18, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- avoid contact with the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
Stop use and consult a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box
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INGREDIENTS AND APPEARANCE
LIDOCAINE
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-824 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine 40 mg in 1 g Inactive Ingredients Ingredient Name Strength Acrylamide (UNII: 20R035KLCI) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Allantoin (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) Benzyl Alcohol (UNII: LKG8494WBH) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOHEXADECANE (UNII: 918X1OUF1E) Polysorbate 80 (UNII: 6OZP39ZG8H) Propylene Glycol (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-824-30 1 in 1 BOX 02/15/2024 1 28.35 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 drug M017 02/15/2024 Labeler - Stratus Pharmaceuticals Inc (789001641) Establishment Name Address ID/FEI Business Operations Tarmac Products Inc 059890491 MANUFACTURE(58980-824)