SUNBURN PAIN RELIEF- lidocaine hydrochloride 0.5% gel

Sunburn Pain relief by

Drug Labeling and Warnings

Sunburn Pain relief by is a Otc medication manufactured, distributed, or labeled by Top Care, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                                             Purpose

Lidocaine Hydrochloride 0.5%                        External analgesic

PURPOSE

Uses for temporary relief of pain and itching due to

• sunburn
• minor burns
• insect bites
• cuts
• scrapes

Warnings

For external use only

When using this product

• avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask a doctor if

symptoms last more than 7 days.

Keep out of reach of the children

Directions

adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times a day
children under 2 years of age: consult a physician

Inactive ingredients

Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80,
Propylene Glycol, Triethanolamine, Water, Yellow 5

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNBURN PAIN RELIEF 
lidocaine hydrochloride 0.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-883
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 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Alcohol (UNII: ND2M416302)
Menthol (UNII: L7T10EIP3A)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-883-06	1 in 1 CARTON	02/12/2016
1		237 mL in 1 BOTTLE; 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	02/12/2016

Labeler - Top Care (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-883) , label(36800-883)