Label: PS-3885 BURN EASE, 3.5G gel
- NDC Code(s): 58228-3885-1
- 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 12, 2023
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INGREDIENTS AND APPEARANCE
PS-3885 BURN EASE, 3.5G
ps-3885 burn ease, 3.5g gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58228-3885 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) IMIDUREA (UNII: M629807ATL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) Product Characteristics Color Score Shape FREEFORM Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58228-3885-1 3000 in 1 CARTON 07/31/2023 1 6 in 1 BAG 1 3.5 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 07/31/2023 Labeler - ProStat First Aid LLC (061263699) Registrant - Dynarex Corporation (008124539)