Sarna Sensitive

Sarna Sensitive
SPL v20
SPL
SPL Set ID 7b2ff573-ca59-d69a-e053-2a91aa0abcec
Route
TOPICAL
Published
Effective Date 2023-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
Polyoxyl 100 Stearate Polyoxyl 8 Stearate Benzyl Alcohol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Cetyl Alcohol Dimethicone Glyceryl Monostearate Isopropyl Myristate Petrolatum Water Sodium Hydroxide Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-02-22 Until 2025-10-31

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
Section 43683-2

Formatted Uses section

Formatted Directions section

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 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive Ingredients

benzyl alcohol, carbomer homopolymer type C, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, petrolatum, PEG-8 stearate, PEG-100 stearate, purified water, sodium hydroxide, stearic acid

Questions Or Comments?

Call 1-833-279-6522

Principal Display Panel

NDC 0316-0230-75

#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

Steroid-Free & Fragrance-Free

Sarna SENSITIVE

Pramoxine Hydrochloride 1%

EXTERNAL ANALGESIC LOTION

ITCH RELIEF

Moisturizes and gently relieves itch associated with:

Eczema and

Dry, Sensitive Skin

Net wt. 7.5 fl oz (222 mL)

P11707.01

Sarna is registered trademark of Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

©2019 Crown Laboratories, Inc.

When Using This Product
  • avoid contact with the 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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


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 43683-2 (43683-2)

Formatted Uses section

Formatted Directions section

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 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer homopolymer type C, 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 1-833-279-6522

Principal Display Panel

NDC 0316-0230-75

#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

Steroid-Free & Fragrance-Free

Sarna SENSITIVE

Pramoxine Hydrochloride 1%

EXTERNAL ANALGESIC LOTION

ITCH RELIEF

Moisturizes and gently relieves itch associated with:

Eczema and

Dry, Sensitive Skin

Net wt. 7.5 fl oz (222 mL)

P11707.01

Sarna is registered trademark of Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

©2019 Crown Laboratories, Inc.

When Using This Product (When using this product)
  • avoid contact with the 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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.


Advanced Ingredient Data


Raw Label Data

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