Label: TOP SAFETY FIRST AID BURN CREAM- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51395-412-01 - Packager: Top Safety Products Company Inc
- 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 March 12, 2019
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- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Stop Use
- Do Not Use
- Directions
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
TOP SAFETY FIRST AID BURN CREAM
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51395-412 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g in 100 g BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) CETETH-20 (UNII: I835H2IHHX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) GLYCERIN (UNII: PDC6A3C0OX) EDETATE SODIUM (UNII: MP1J8420LU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51395-412-01 2000 in 1 BOX 02/16/2016 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/07/2016 Labeler - Top Safety Products Company Inc (627999956)