GOODSENSE BURN RELIEF GEL- lidocaine hcl gel

GoodSense Burn Relief Gel by

Drug Labeling and Warnings

GoodSense Burn Relief Gel 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 Ingredients

Lidocaine 0.5%

Purpose

Topical Analgesic

Uses

• tempory relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, minor skin irritations, and insect bites.

Dosage & Administration

For 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 this in large quantities, particularly over raw surfaces or blistered areas.

When using this product

When using this product avoid contact with the eyes.

Stop use and ask a doctor

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

Keep out of reach of children.

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

Directions

• 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: do not use, ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Blue 5, Carbomer. Disodium, EDTA Glycerin, Menthol, Phenoxyethanol, Polysorbate 20, Propanediol, SD Alcohol (1.85% w/w). Sodium Hydroxide, Water, Yellow 5

Questions or Comments?

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Principal Display Panel

GOODSENSE

BURN RELIEF

GEL

with

Lidocaine HCl

• Soothes & Relieves
• Restores Moisture
• Topical Analgesic Gel

with ALOE

Compare to active ingredients of

Solarcaine

100% satisfaction guaranteed

NET WT 8 OZ (226 g)

PKLA-41212-GSF1

INGREDIENTS AND APPEARANCE

GOODSENSE BURN RELIEF GEL 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-618
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BASIC YELLOW 5 (UNII: 07BP340B4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-618-26	226 g in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/04/2019

Labeler - Solskyn Personal Care LLC (080010329)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Piedmont LLC		078482780	manufacture(70281-618)