FDA.reportPublic FDA data

Sarna

Manufacturer
Crown Laboratories | Crown Laboratories, Inc.
Effective date
2024-05-31
Label type
HUMAN OTC DRUG LABEL
Version
20
Source
full-release
Hydrated at
2026-06-01 00:13:16

Label at a glance#

ProductSarna
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-833-279-6522

RECENT MAJOR CHANGES SECTION

Formatted Uses section

Formatted Directions section

Principal Display Panel

PACKAGE LABEL.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.

p1170101p1170101

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0230-752023-02-13C16284748780-1f386c64a-0288-0266-e053-dadaa90a7c1aSarna Sensitive
0316-0230-752023-01-30C16284748780-1f386c64a-0288-0266-e053-dadaa90a7c1aSarna Sensitive

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0230SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [CROWN LABORATORIES]20Current NDC, Legacy NDC20240602_7b2ff573-ca59-d69a-e053-2a91aa0abcec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0230-75ML - Milliliter0316-0230c47fd8d6-cdae-4078-8f6f-5cdc699dcd3b12019-01-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02300316-0230-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYOXYL 100 STEARATEYD01N1999RIACT
POLYOXYL 8 STEARATE2P9L47VI5EIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
ndc (product): 0316-0230
19c3ab88-2e24-5da3-e063-6294a90acd667b2ff573-ca59-d69a-e053-2a91aa0abcec2024-05-31WarningsExact identifier
spl id: 19c3ab88-2e24-5da3-e063-6294a90acd66
spl set id: 7b2ff573-ca59-d69a-e053-2a91aa0abcec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.