Label: FIRST DEGREE MAXIMUM STRENGTH BURN- pramoxine hydrochloride cream
- NDC Code(s): 24330-130-02
- Packager: Welmedix LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 9, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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- Other information
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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
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 21 g Tube Box
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INGREDIENTS AND APPEARANCE
FIRST DEGREE MAXIMUM STRENGTH BURN
pramoxine hydrochloride creamProduct 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)