Label: FIRST AID BURN CREAM cream
- NDC Code(s): 58228-2044-1, 58228-2044-2
- Packager: ProStat First Aid LLC
- Category: HUMAN OTC DRUG LABEL
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 16, 2023
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- Active Ingredient
- 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
- Questions?
- 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:58228-2044 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) 0.13 g in 100 g LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) WATER (UNII: 059QF0KO0R) EDETATE SODIUM (UNII: MP1J8420LU) CETETH-20 (UNII: I835H2IHHX) DIMETHICONE 350 (UNII: 2Y53S6ATLU) Product Characteristics Color Score Shape FREEFORM Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58228-2044-2 1800 in 1 CASE 04/10/2023 1 NDC:58228-2044-1 25 in 1 BOX 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 04/10/2023 Labeler - ProStat First Aid LLC (061263699)