FIRST DEGREE MAXIMUM STRENGTH BURN- pramoxine hydrochloride cream 
Welmedix 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:

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

Other information

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

PRINCIPAL DISPLAY PANEL - 21 g Tube Box

NEW &
IMPROVED!

First°Degree®

MAXIMUM STRENGTH
BURN CREAM
PRAMOXINE HCL 1% PAIN RELIEVING CREAM

FAST RELIEF FOR
PAIN + ITCH

1 Tube
Net Wt 3/4 oz (21 g)

Principal Display Panel - 21 g Tube Box
FIRST DEGREE MAXIMUM STRENGTH BURN 
pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-130
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:24330-130-021 in 1 BOX03/09/2017
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 FINALpart34803/09/2017
Labeler - Welmedix LLC (830387812)

Revised: 3/2017
Document Id: cbfe71fd-2d5c-4c98-8caf-68fe49e54b6f
Set id: 1afa337e-f411-42df-b2f5-5f72c9b52ffa
Version: 1
Effective Time: 20170309
 
Welmedix LLC