FDA.reportPublic FDA data

Sarna

Manufacturer
Crown Laboratories, Inc
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:25

Label at a glance#

ProductSarna
Active ingredientMENTHOL, PRAMOXINE HYDROCHLORIDE
Label structure9 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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5%

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

When using this product

OTC - WHEN USING SECTION

  • 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

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, 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

Questions?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Sarna Calm + Cool Principal Display Panel

PACKAGE LABEL.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

Sarna Calm_CoolSarna Calm_Cool

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixP12288.00Sarna Calm_Cool P12288.00.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
0316-0234-12Sarna355 mL in 1 BOTTLE, PUMPLOTION3554
0316-0234-24Sarna5 mL in 1 PACKETLOTION54
0316-0234-75Sarna222 mL in 1 BOTTLE, PUMPLOTION2224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0234-75ML - Milliliter0316-0234f4af0a21-56e8-4d73-8123-a698e7314b4712024-08-12

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
0316-02340316-0234-75, 0316-0234-12, 0316-0234-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
MENTHOLL7T10EIP3AACTIB
PEG-100 STEARATEYD01N1999RIACT
BENZYL ALCOHOLLKG8494WBHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
PENTYLENE GLYCOL50C1307PZGIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
ALOE VERA LEAFZY81Z83H0XIACT
PEG-8 STEARATE2P9L47VI5EIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
PALMITIC ACID2V16EO95H1IACT
SODIUM HYDROXIDE55X04QC32IIACT
YEAST .BETA.-D-GLUCAN44FQ49X6UNIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-10-15monthly-update2026-06-03 17:38:43
22025-03-21full-release2026-06-01 00:57:34

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 HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
ndc (package): 0316-0234-75
ndc (package): 0316-0234-12
ndc (package): 0316-0234-24
ndc (product): 0316-0234
ndc11 (package): 00316023475
ndc11 (package): 00316023412
ndc11 (package): 00316023424
spl id: 483436b1-9031-4992-e063-6394a90ad0c5
spl set id: 19c41e75-a654-90cf-e063-6394a90a7e97

Reported adverse events (FAERS/openFDA)#

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