FIRST DEGREE MAXIMUM STRENGTH BURN- pramoxine hydrochloride cream

First Degree Maximum Strength Burn by

Drug Labeling and Warnings

First Degree Maximum Strength Burn by is a Otc medication manufactured, distributed, or labeled by Welmedix LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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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

• GREAT FOR
  MINOR
  BURNS
  BUG
  BITES
• HELPS REDUCE THE APPEARANCE OF SCARS
• ENRICHED WITH NOURISHING BOTANICALS

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

INGREDIENTS AND APPEARANCE

FIRST DEGREE MAXIMUM STRENGTH BURN 
pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24330-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24330-130-02	1 in 1 BOX	03/09/2017
1		21 g in 1 TUBE; 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	03/09/2017

Labeler - Welmedix LLC (830387812)