Sarna Sensitive

Sarna Sensitive
SPL v5
SPL
SPL Set ID 19b0ce1b-e147-01a1-e063-6394a90af808
Route
TOPICAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
Sodium Hydroxide Benzyl Alcohol Pentylene Glycol Saccharide Isomerate Glyceryl Monostearate Aloe Vera Leaf Ethylhexylglycerin Simmondsia Chinensis Seed Tocopherol Water Peg-100 Stearate Peg-8 Stearate Squalane Caprylyl Glycol Isopropyl Myristate Palmitic Acid Sodium Citrate Carbomer Homopolymer Type C Cetyl Alcohol Citric Acid Monohydrate Yeast .beta.-d-glucan Dimethicone Stearic Acid

Identifiers & Packaging

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

Description

Pramoxine Hydrochloride 1%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Pramoxine Hydrochloride 1%

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.

Directions
  • To open, hold cap and turn pump 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: do not use, consult a doctor.
Do Not Use
  • in the eyes
  • over large areas of the body
  • for prolonged periods
Active Ingredient

Pramoxine Hydrochloride 1%

Other Information
  • store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citric Acid, Dimethicone, Ethylhexylglycerin, Glyceryl Stearate, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Citrate, Sodium Hydroxide, Squalane, Stearic Acid, Tocopherol, Water

When Using This Product
  • avoid contact with eyes
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Stop Use and Ask A Doctor If
  • redness, irritation, swelling, or pain persists or increases.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Sarna Sensitive Principal Display Panel

#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

Sarna

Pramoxine Hydrochloride 1%

External Analgesic Lotion

Steroid Free

SENSITIVE

ANTI-ITCH LOTION

  • Eases itch associated with minor skin irritations
  • Soothes and conditions with Aloe, Squalene, and Jojoba Oil
  • Hypoallergenic

NET WT. 7.5fl oz (222 ml)

P12305.01


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

Purpose

External analgesic

Warnings

For external use only.

Directions
  • To open, hold cap and turn pump 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: do not use, consult a doctor.
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • for prolonged periods
Active Ingredient (Active ingredient)

Pramoxine Hydrochloride 1%

Other Information (Other information)
  • store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citric Acid, Dimethicone, Ethylhexylglycerin, Glyceryl Stearate, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Citrate, Sodium Hydroxide, Squalane, Stearic Acid, Tocopherol, Water

When Using This Product (When using this product)
  • avoid contact with eyes
  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness, irritation, swelling, or pain persists or increases.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Sarna Sensitive Principal Display Panel

#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

Sarna

Pramoxine Hydrochloride 1%

External Analgesic Lotion

Steroid Free

SENSITIVE

ANTI-ITCH LOTION

  • Eases itch associated with minor skin irritations
  • Soothes and conditions with Aloe, Squalene, and Jojoba Oil
  • Hypoallergenic

NET WT. 7.5fl oz (222 ml)

P12305.01


Advanced Ingredient Data


Raw Label Data

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