DERMELEVE- pramoxine hydrochloride cream

Dermeleve by

Drug Labeling and Warnings

Dermeleve by is a Otc medication manufactured, distributed, or labeled by Advanced Derm Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Pramoxine Hydrochloride (1%)

Purpose

External analgesic

Uses

For temporary relief of pain and itching associated with skin irritations, minor burns, sunburn, and rashes due to poison ivy, poison oak, or poison sumac

Warnings

• For external use only.
• Avoidcontact with eyes. 
• Do not apply to open wounds. 
• STOP USE and ask a doctor if condition worsens or symptoms persist for more than seven days. 
• Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and children two years of age and older, apply to affected area as needed or as directed by a doctor.

Consult a doctor for children under the age of two.

SPL UNCLASSIFIED SECTION

Store at 20-25ºC (68-77ºF). Keep carton for full product information

SPL UNCLASSIFIED SECTION

Questions? Visit www.dermeleve.com or call +1 (877)-684-2299

Inactive ingredients

Ascorbyl Tetraispalmitate, Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol
Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate Crosspolymer-6, Polysorbate 60, Propylene Glycol, Sodium Hyaluronate, Strontium Nitrate, Tocopherol Acetate (Vitamin E), Water, Xanthan Gum

Product label

INGREDIENTS AND APPEARANCE

DERMELEVE 
pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81507-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE 100 (UNII: RO266O364U)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
HYALURONIC ACID (UNII: S270N0TRQY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
CERAMIDE NG (UNII: C04977SRJ5)
WATER O-18 (UNII: 7QV8F8BYNJ)
MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TOCOPHEROL (UNII: R0ZB2556P8)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STRONTIUM NITRATE (UNII: BDG873AQZL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81507-005-01	1 in 1 BOX	11/01/2024
1		60 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 81507-005-02	1 in 1 BOX	11/01/2024
2		120 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 Drug	M016	11/01/2024

Labeler - Advanced Derm Solutions LLC (117840544)