Sarna Calm + Cool

Sarna Calm + Cool
SPL v4
SPL
SPL Set ID 19c41e75-a654-90cf-e063-6394a90a7e97
Route
TOPICAL
Published
Effective Date 2024-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.5 mg) Pramoxine (10 mg)
Inactive Ingredients
Stearic Acid Peg-100 Stearate Benzyl Alcohol Caprylyl Glycol Tocopherol Water Carbomer Homopolymer Type C Pentylene Glycol Glyceryl Monostearate Butylene Glycol Cetyl Alcohol Ethylhexylglycerin Isopropyl Myristate Hamamelis Virginiana Leaf Aloe Vera Leaf Peg-8 Stearate Dimethicone Glycerin Palmitic Acid Sodium Hydroxide Yeast .beta.-d-glucan

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-05

Description

Menthol 0.5% Pramoxine Hydrochloride 1%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Menthol 0.5% 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 or nose
  • over large areas of the body
  • for prolonged periods
Questions?

call 1-833-279-6522

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

Menthol 0.5%

Pramoxine Hydrochloride 1%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, Water

When Using This Product
  • avoid contact with the 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 Calm + Cool Principal Display Panel

#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

Sarna

Pramoxine Hydrochloride 1%

Menthol 0.5%

External Analgesic Lotion

Steroid Free

CALM + COOL

ANTI-ITCH LOTION

Eases pain and itch associated with insect bites, sunburn, and poison ivy

Infused with Witch Hazel Extract

Cools with Menthol

NET WT. 7.5fl oz (222 ml)

P12288.00


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 or nose
  • over large areas of the body
  • for prolonged periods
Questions?

call 1-833-279-6522

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

Menthol 0.5%

Pramoxine Hydrochloride 1%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, Water

When Using This Product (When using this product)
  • avoid contact with the 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 Calm + Cool Principal Display Panel

#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

Sarna

Pramoxine Hydrochloride 1%

Menthol 0.5%

External Analgesic Lotion

Steroid Free

CALM + COOL

ANTI-ITCH LOTION

Eases pain and itch associated with insect bites, sunburn, and poison ivy

Infused with Witch Hazel Extract

Cools with Menthol

NET WT. 7.5fl oz (222 ml)

P12288.00


Advanced Ingredient Data


Raw Label Data

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