Label: 4 LIDOCAINE TOPICAL ANESTHETIC- lidocaine cream
- NDC Code(s): 0536-1267-20
- Packager: RUGBY LABORATORIES
- 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.
Drug Label Information
Updated April 7, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
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Warnings
For external use only.
When using this product
- do not use in or near the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas.
- Directions
- Other information
- Inactive ingredients
- Questions & Comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
4 LIDOCAINE TOPICAL ANESTHETIC
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1267 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLESTEROL (UNII: 97C5T2UQ7J) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1267-20 15 g in 1 BOX; Type 0: Not a Combination Product 04/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/30/2020 Labeler - RUGBY LABORATORIES (079246066)