BURN RELIEF- lidocaine spray

Burn Relief by

Drug Labeling and Warnings

Burn Relief by is a Otc medication manufactured, distributed, or labeled by Solskyn Personal Care LLC, KIK Piedmont LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 0.5%

Purpose

External analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:

Sunburn Minor burns

Minor cuts Scrapes

Insect bites Minor skin irritations

Dosage & Administration

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

Warnings

For external use only.

Do not use

Do not use in large quantities, particularly over raw surfaces or

blistered areas.

When using this product:

When using this product:
Keep out of eyes.
Use only as directed.
Do not puncture or incinerate. Contents under pressure. Do
not store at temperature above 120°F.

Stop use and ask a doctor if:

Stop use and ask a doctor if:

Condition gets worse

Symptoms last more than 7 days

Symptoms clear up and occur again in a few days

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or

contact Poison Control Center right away.

Directions

Shake well

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: ask a doctor

To apply to face, spray on palm of hand and gently apply

Inactive Ingredients

Water, Glycerin, Propanediol, Aloe Barbadensis Leaf Juice,

Carbomer, Tocopheryl Acetate, PEG-40 Hydrogenated Castor Oil,

Sodium Lauroyl Sarcosinate, Disodium EDTA, Phenoxyethanol,

Sodium Hydroxide

Questions or comments?

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

800-715-3485

Principal Display Panel

GoodSense

Burn Relief

Continuous Spray

Topical Analgesic

With LidocainepROVIDES FAST RELIEF FROM:

• Sunburn
• Cuts & scrapes
• Insect bites,
• Minor burn & sunburn

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NET WT 6 OZ (170 g)

INGREDIENTS AND APPEARANCE

BURN RELIEF 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-640
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-640-06	170 g in 1 CAN; Type 0: Not a Combination Product	04/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/03/2019

Labeler - Solskyn Personal Care LLC (080010329)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Piedmont LLC		078482780	manufacture(70281-640)