SPL v1
SPL
SPL Set ID 5f448090-642c-4c36-a53d-2aab9c1398b4
Route
TOPICAL
Published
Effective Date 2024-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g)
Inactive Ingredients
Isopropyl Myristate Caprylic/capric Mono/di-glycerides Cetostearyl Alcohol Dimethicone 100 Polyacrylic Acid (450000 Mw) Hyaluronic Acid Propylene Glycol Polawax Polysorbate Glycerin Caprylyl Glycol Xanthan Gum Ceramide Ng Water O-18 Magnesium Aluminum Silicate Type Ia Glyceryl Stearate Se Edetate Disodium Tocopherol Tetrahexyldecyl Ascorbate Shea Butter Phenoxyethanol Strontium Nitrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01
Description

Pramoxine Hydrochloride (1%)

Purpose

External analgesic

Medication Information

Purpose

External analgesic

Description

Pramoxine Hydrochloride (1%)

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

Section 42229-5

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

Section 50565-1

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.
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.

Product Label

Active Ingredient

Pramoxine Hydrochloride (1%)

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

Structured Label Content

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Purpose

External analgesic

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.
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.

Product Label (Product label)

Active Ingredient

Pramoxine Hydrochloride (1%)

Inactive Ingredients (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:10.236363 · Updated: 2026-03-14T23:04:41.766336