FIRST DEGREE MAXIMUM STRENGTH BURN- pramoxine hydrochloride cream 
Denison Pharmaceuticals, LLC.

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.

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First° Degree ® Maximum Strength Burn Cream

Drug Facts

Active ingredient

Pramoxine HCL 1%

Purpose

External analgesic

Uses

For the temporary relief of pain and itching associated with:

  • minor burns
  • insect bites
  • sunburns
  • minor cuts
  • scrapes
  • minor skin irritations

Warnings

For external use only. Avoid contact with the eyes

Do not use

  • if you are allergic to any of the ingredients
  • over large areas of the body

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 2 years of age and older:
    • clean the affected area
    • apply to affected area not more than 3 to 4 times daily
    • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, calendula officinalis extract, cantharis vesicatoria extract, echinacea angustifolia extract, ethyl alcohol, hydrogenated polydecene, isopropyl myristate, lanolin, lanolin alcohol, petrolatum, phenoxyethanol, water, sodium hydroxide, sodium polyacryloyldimethyl taurate, trideceth-10

Questions or Comments?

1-888-565-2876
Monday through Friday, 9am-5pm EST

Distributed by:
Welmedix Consumer Healthcare
Princeton, NJ 08540

FIRST DEGREE MAXIMUM STRENGTH BURN (PRAMOXINE HYDROCHLORIDE) CREAM

Label Image
FIRST DEGREE MAXIMUM STRENGTH BURN 
pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1043
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
LYTTA VESICATORIA (UNII: 3Q034RO3BT)  
GUAR GUM (UNII: E89I1637KE)  
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM TAURATE (UNII: Y7LJA74T0N)  
TRIDECETH-10 (UNII: G624N6MSBA)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1043-381 in 1 BOX01/01/2017
121 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/201701/20/2022
Labeler - Denison Pharmaceuticals, LLC. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC.001207208manufacture(0295-1043)

Revised: 1/2022
Document Id: d60be481-25fa-2d9b-e053-2995a90abbe0
Set id: 610dfa03-8a99-4fa6-b17b-8aa1ba966674
Version: 3
Effective Time: 20220120
 
Denison Pharmaceuticals, LLC.