FDA.reportPublic FDA data

Sarna

Manufacturer
Crown Laboratories | Crown Laboratories, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:32:25

Label at a glance#

ProductSarna
Active ingredientPRAMOXINE HYDROCHLORIDE
Label structure8 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 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.

Storage and handling

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

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.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body
  • for prolonged periods

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • redness, irritation, swelling, or pain persists or increases.

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 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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Sarna Sensitive Principal Display Panel

PACKAGE LABEL.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

sensitive fr labelsensitive fr label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1246075pramoxine HCl 1 % Topical LotionPSN5
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD5
1246075pramoxine hydrochloride 1 % Topical LotionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0230-12Sarna355 mL in 1 BOTTLE, PUMPLOTION3555
0316-0230-25Sarna5 mL in 1 PACKETLOTION55
0316-0230-57Sarna222 mL in 1 BOTTLE, PUMPLOTION2225

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 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02300316-0230-57, 0316-0230-12, 0316-0230-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
BENZYL ALCOHOLLKG8494WBHIACT
PENTYLENE GLYCOL50C1307PZGIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
PEG-100 STEARATEYD01N1999RIACT
PEG-8 STEARATE2P9L47VI5EIACT
SQUALANEGW89575KF9IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PALMITIC ACID2V16EO95H1IACT
SODIUM CITRATE1Q73Q2JULRIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
YEAST .BETA.-D-GLUCAN44FQ49X6UNIACT
DIMETHICONE92RU3N3Y1OIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-11-12monthly-update2026-06-03 17:39:36
22025-03-21full-release2026-06-01 00:57:33

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
ndc (package): 0316-0230-57
ndc (package): 0316-0230-25
ndc (package): 0316-0230-12
ndc (product): 0316-0230
ndc11 (package): 00316023012
ndc11 (package): 00316023057
ndc11 (package): 00316023025
spl id: 48341fc1-10ea-47fa-e063-6394a90abe32
spl set id: 19b0ce1b-e147-01a1-e063-6394a90af808

Reported adverse events (FAERS/openFDA)#

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