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

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

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

Inactive ingredients

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?

Call 1-833-279-6522

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

p1170101

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
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0316-0230-75	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	02/22/2011

Labeler - Crown Laboratories (079035945)

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

Sarna Sensitive