SARNA- pramoxine hydrochloride lotion
Stiefel Laboratories, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 or below 30ºC (86ºF)

Inactive ingredients

benzyl alcohol, carbomer homopolymer type C, cetyl alcohol, dimethicone, glyceryl monostearate, isopropyl myristate, petrolatum, polyoxyl 8 stearate, polyoxyl 100 stearate, purified water, sodium hydroxide, stearic acid

Questions or comments?

Call 1-888-438-7426

Principal Display Panel

DERMATOLOGIST Recommended

NDC 0145-0630-05

Steroid-Free and Fragrance-Free

Sarna

SENSITIVE

Pramoxine Hydrochloride 1%

EXTERNAL ANALGESIC LOTION

ANTI-ITCH

•: Relieves itching associated with:
: DRY, SENSITIVE AND ECZEMA PRONE SKIN
•: Moisturizing

Stiefel

Skin Science Solutions

NET WT 7.5 fl oz (222 mL)

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

Stiefel Laboratories, Inc.

Research Triangle Park

NC 27709

Made in Canada

Front Label: 106085XA

SARNA
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0145-0630
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0145-0630-05	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/22/2011	09/30/2020
2	NDC:0145-0630-62	20 in 1 CARTON	02/22/2011	12/31/2019
2	NDC:0145-0630-61	5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/22/2011	09/30/2020

Labeler - Stiefel Laboratories, Inc (808842343)

Name	Address	ID/FEI	Business Operations
Establishment
KIK HOLDCO COMPANY INC.		243547333	MANUFACTURE(0145-0630)

Revised: 1/2019

Document Id: 744f8f8a-11d2-4ac3-9683-db916f2e4c5c

Set id: 6fe48995-0b1c-48dd-bc6e-5d41b31a6486

Version: 14

Effective Time: 20190123

Stiefel Laboratories, Inc