Active Ingredients

Menthol 0.5%

Pramoxine Hydrochloride 1%

Purpose

External analgesic

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.

Do not use

in the eyes or nose
over large areas of the body
for prolonged periods

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.

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.

Other information

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

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

Questions?

call 1-833-279-6522

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

Sarna Calm_Cool

SARNA
pramoxine hydrochloride, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0316-0234
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1000 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 mg in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
PEG-100 STEARATE (UNII: YD01N1999R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0316-0234-75	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/05/2024
2	NDC:0316-0234-12	355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/05/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/05/2024

Labeler - Crown Laboratories, Inc (079035945)

Name	Address	ID/FEI	Business Operations
Establishment
Crown Laboratories, Inc		079035945	manufacture(0316-0234)

Name	Address	ID/FEI	Business Operations
Establishment
VOYANT BEAUTY, INC.		243547333	manufacture(0316-0234)