NDC 0295-1043

First Degree Maximum Strength Burn

Pramoxine Hydrochloride

First Degree Maximum Strength Burn is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Denison Pharmaceuticals, Llc.. The primary component is Pramoxine Hydrochloride.

Product ID0295-1043_620ccba1-f64c-4e49-86a8-f2894c2f114f
NDC0295-1043
Product TypeHuman Otc Drug
Proprietary NameFirst Degree Maximum Strength Burn
Generic NamePramoxine Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameDenison Pharmaceuticals, LLC.
Substance NamePRAMOXINE HYDROCHLORIDE
Active Ingredient Strength10 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0295-1043-38

1 TUBE in 1 BOX (0295-1043-38) > 21 g in 1 TUBE
Marketing Start Date2017-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0295-1043-38 [00295104338]

First Degree Maximum Strength Burn CREAM
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-01

Drug Details

Active Ingredients

IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/g

OpenFDA Data

SPL SET ID:610dfa03-8a99-4fa6-b17b-8aa1ba966674
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1052684

    • NDC Crossover Matching brand name "First Degree Maximum Strength Burn" or generic name "Pramoxine Hydrochloride"

    NDCBrand NameGeneric Name
    0295-1043First Degree Maximum Strength BurnPramoxine Hydrochloride
    24330-130First Degree Maximum Strength BurnPramoxine Hydrochloride
    49967-512CeraVe Developed with Dermatologists Itch Relief Moisturizingpramoxine hydrochloride
    49967-970CeraVe Developed with Dermatologists Itch Relief Moisturizingpramoxine hydrochloride
    0187-1970CeraVe Itch Relief Moisturizingpramoxine hydrochloride
    0187-1975CeraVe Itch Relief Moisturizingpramoxine hydrochloride
    12258-223CurasorePramoxine Hydrochloride
    11822-0405CVS Fragrance Free Anti-ItchPRAMOXINE HYDROCHLORIDE
    59779-052CVS Fragrance Free Anti-ItchPRAMOXINE HYDROCHLORIDE
    59088-685CVS Maximum Strength Feminine Anti-Itch WipesPramoxine Hydrochloride
    59779-993CVS PharmacyPramoxine Hydrochloride
    0496-0586DerMend Moisturizing Anti-Itchpramoxine hydrochloride
    41167-0511Gold Bond Intensive Healing Anti Itch Skin ProtectantPramoxine Hydrochloride
    0395-0119Ivy WashPramoxine Hydrochloride
    49781-105Leader Poison Ivy WashPramoxine Hydrochloride
    54897-601LUVENA FEMININE WIPESPramoxine Hydrochloride
    51862-180Pramoxine hydrochloridePramoxine hydrochloride
    0496-0748PRAXpramoxine hydrochloride
    50268-682PRAXpramoxine hydrochloride
    0802-0119Private Label Poison Ivy WashPramoxine Hydrochloride
    0037-6823PROCTOFOAMpramoxine hydrochloride
    10956-799ReesesPramoxine Hydrochloride
    66184-160Sally Hansen Zero bump bikiniPRAMOXINE HYDROCHLORIDE
    0145-0630Sarnapramoxine hydrochloride
    0316-0230Sarnapramoxine hydrochloride
    11509-5035VAGISIL Anti-Itch Medicated Wipes Maximum Strengthpramoxine hydrochloride
    11509-5058VAGISIL Anti-Itch Medicated Wipes Maximum Strengthpramoxine hydrochloride
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