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 Denison Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

FIRST DEGREE MAXIMUM STRENGTH BURN (PRAMOXINE HYDROCHLORIDE) CREAM

INGREDIENTS AND APPEARANCE

FIRST DEGREE MAXIMUM STRENGTH BURN 
pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1043
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: 0295-1043-38	1 in 1 BOX	01/01/2017
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	01/01/2017

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	manufacture(0295-1043)