SARNA- camphor and menthol lotion
Crown Laboratories

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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Sarna Original

Active ingredients

Camphor 0.5%

Menthol 0.5%

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 care 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

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

Questions or comments?

Call 1-833-279-6522

Principal Display Panel

#1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

NDC 0316-0229-75

Steroid-Free

Sarna ORIGINAL

Camphor 0.5%, Menthol 0.5%

EXTERNAL ANALGESIC LOTION

ITCH RELIEF

Cools and soothes itch associated with:

Insect Bites

Poison Ivy

Sunburn

Soothes irritated skin

Net wt. 7.5 fl oz (222 mL)

Sarna is registered trademark of Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

p1170601

SARNA
camphor and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0316-0229
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0316-0229-75	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 not final	part348	02/22/2011

Labeler - Crown Laboratories (079035945)

Name	Address	ID/FEI	Business Operations
Establishment
Crown Laboratories, Inc.		079035945	manufacture(0316-0229)

Revised: 9/2021

Document Id: ccfc6e1c-b9e0-326e-e053-2a95a90a09fb

Set id: 7b2ff573-ca5a-d69a-e053-2a91aa0abcec

Version: 16

Effective Time: 20210927

Crown Laboratories