Label: FIRST AID BURN CREAM cream
- NDC Code(s): 58228-2309-1
- Packager: ProStat First Aid LLC
- 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 July 11, 2023
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- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Use(s)
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Warnings
For External Use Only.
Do not use
• In the eyes • Over large areas of the body or on deep puncture wounds, animal bites, or serious burns • In large quantities, particularly over raw surfaces or blistered areas
- Directions
- Other Information
- Inactive Ingredients
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- Label
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INGREDIENTS AND APPEARANCE
FIRST AID BURN CREAM
first aid burn cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58228-2309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 50 mg in 10000 mg BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 13 mg in 10000 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE SODIUM (UNII: MP1J8420LU) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) CETETH-20 (UNII: I835H2IHHX) DIMETHICONE 350 (UNII: 2Y53S6ATLU) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Product Characteristics Color Score Shape FREEFORM Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58228-2309-1 2000 in 1 CARTON 07/31/2023 1 900 mg 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 07/31/2023 Labeler - ProStat First Aid LLC (061263699) Registrant - Dynarex Corporation (008124539)