Peviderm Pramoxine Hydrocholride 1% Lotion
FDA Label NDC 58980-913

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals Inc for the product Peviderm Pramoxine Hydrocholride 1% (NDC 58980-913). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed by:
STRATUS
PHARMACEUTICALS INC
Miami, Florida 33186

Active Ingredient

Pramoxine Hydrochloride 1%

Purpose

External Analgesic

Uses

  • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

Warnings

for external use only

When Using This Product

  • avoid contact with eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center immediately

Directions

  • to open, hold cap tightly and turn pump counter-clockwise

    • Adults and children 2 years of age and older:

    • apply to affected area not more than 3 to 4 times daily

      • Children under 2 years of age:

      • consult a doctor

Other Information

  • Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]

Inactive Ingredients

Benzyl Alcohol, Carbomer 940, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Isopropyl Myristate, Petrolatum, PEG-8 Stearate, PEG-100 Stearate, Purified Water, Sodium Hydroxide, Stearic Acid.

Questions Or Comments?

Call us at 1-800-442-7882

Principal Display Panel - 222 Ml Bottle Box

NDC 58980-913-80

Steroid-Free & Fragrance-Free

PEVIDERM™
PRAMOXINE HYDROCHLORIDE 1%

ITCH RELIEF FOR SENSITIVE SKIN

EXTERNAL
ANALGESIC LOTION

Moisturizes and gently relieves
itch associated with:
Eczema and
Dry Sensitive Skin

Net 7.5 fl oz (222 mL)

Principal Display Panel (222 mL Bottle Box)

Principal Display Panel (222 mL Bottle Box)

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