Active ingredient

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
over large areas of the body
for prolonged periods

When using this product

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

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, 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

#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)

Sarna Sensitive

SARNA
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0316-0230
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 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
SQUALANE (UNII: GW89575KF9)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0316-0230-57	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2024
2	NDC:0316-0230-12	355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2024

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

Labeler - Crown Laboratories (079035945)

Name	Address	ID/FEI	Business Operations
Establishment
Crown Laboratories, Inc.		079035945	manufacture(0316-0230)

Name	Address	ID/FEI	Business Operations
Establishment
VOYANT BEAUTY, INC.		243547333	manufacture(0316-0230)