Sunburn Relief (Lidocaine 0.5%) Spray [Topcare] -

SUNBURN RELIEF (LIDOCAINE 0.5%) SPRAY [TOPCARE]
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NDC	36800-721-05
Set ID	1a75c1ca-51fb-4850-a48f-54e6ec427f46
Category	HUMAN OTC DRUG LABEL
Packager	Topcare
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Topcare (006935977)

Registrant - Product Quest Mfg (927768135)

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

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