SUNBURN RELIEF- lidocaine 0.5% spray

Sunburn Relief by

Drug Labeling and Warnings

Sunburn Relief by is a Otc medication manufactured, distributed, or labeled by Topcare, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                            Purpose

Lidocaine 0.5%                               External analgesic

PURPOSE

Uses

Temporarily relieves pain and itching due to

sunburn minor burns minor cuts scrapes

insect bites minor skin irritation

Warnings

For external use only

Flammable: Do not spray while smoking or near heat or flame

Do not use in large quantities, particulary over raw surfaces or blistered areas.

When using this product

• keep out of your eyes
• use only as directed
• do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F.

Keep out of reach of the children

If swallowed, get medical help or contact a 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 into palm of hand and gently apply

Inactive ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Diazolidinyl Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate, Triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNBURN RELIEF 
lidocaine 0.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-721
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-721-05	170 g in 1 CAN; Type 0: Not a Combination Product	12/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/29/2016

Labeler - Topcare (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-721) , label(36800-721)