SARNA- camphor and menthol lotion

Sarna by

Drug Labeling and Warnings

Sarna by is a Otc medication manufactured, distributed, or labeled by Stiefel Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 or below 30°C (86°F)

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 1-888-438-7426

Principal Display Panel

NDC: 0145-0628-05

ORIGINAL

Sarna

Camphor 0.5%, Menthol 0.5%

EXTERNAL ANALGESIC LOTION

DERMATOLOGIST Recommended

Steroid-Free

ANTI-ITCH

• Relieves itching associated with:
•   DRY SKIN
•   INSECT BITES
•   POISON IVY/OAK/SUMAC
•   SUNBURN
• Soothes irritated skin

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

©2017 GSK or its licensor

Front Label: 106083XA

Back Label: 106084XB

INGREDIENTS AND APPEARANCE

SARNA 
camphor and menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0145-0628
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.6 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.6 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0145-0628-05	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/22/2011	10/31/2020
2	NDC: 0145-0628-62	20 in 1 CARTON	02/22/2011	01/30/2020
2	NDC: 0145-0628-61	5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/22/2011	10/31/2020

Labeler - Stiefel Laboratories, Inc (808842343)