Peviderm Pramoxine Hydrocholride 1%

Peviderm Pramoxine Hydrocholride 1%
SPL v2
SPL
SPL Set ID 680b40fa-1922-443a-a4b0-7c3f6a2b847d
Route
TOPICAL
Published
Effective Date 2024-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 mg)
Inactive Ingredients
Water Glyceryl Stearate/peg-100 Stearate Peg-8 Stearate Calcium Chloride Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Palmitate Isopropyl Myristate White Petrolatum Stearic Acid Benzyl Alcohol Sodium Hydroxide

Identifiers & Packaging

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

Description

Drug Facts

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 53414-9

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

Warnings

for external use only

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
Active Ingredient

Pramoxine Hydrochloride 1%

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

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
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)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 53414-9 (53414-9)

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

Purpose

External Analgesic

Warnings

for external use only

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
Active Ingredient (Active ingredient)

Pramoxine Hydrochloride 1%

Other Information (Other information)
  • Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]
Inactive Ingredients (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? (Questions or comments?)

Call us at 1-800-442-7882

When Using This Product (When using this product)
  • avoid contact with eyes
Stop Use and Ask A Doctor If (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
Principal Display Panel 222 Ml Bottle Box (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)