INSTANT BURN RELIEF ALOE EXTRA CVS- lidocaine 0.50% spray

Instant Burn Relief Aloe Extra by

Drug Labeling and Warnings

Instant Burn Relief Aloe Extra by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actives

Lidocaine USP .50%

Purpose

External analgesic

Uses

Temporarily relieves pain and itching due to:

• sunburn
• minor burns
• scrapes
• insect bites
• minor irritations

Warnings

For external use only.

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

Do not use

in large quantities, particularly over raw surfaces or blistered areas

When using this product

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

Stop use and ask a doctor if

• conditions gets worse
• symptoms last more than 7 days
• symptoms clear up and occur again in a few days

Keep out of reach of 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 3-4 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, SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.

PRINCIPAL DISPLAY PANEL

CVS

pharmacy

​INSTANT

BURN RELIEF

SPRAY

ALOE EXTRA

• instant pain relief with Lidocaine
• Cooling, moisturizing itch relief

Net WT 4.5 OZ (127g)

INGREDIENTS AND APPEARANCE

INSTANT BURN RELIEF ALOE EXTRA  CVS
lidocaine 0.50% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	.50 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-230-04	127 g in 1 CAN; Type 0: Not a Combination Product	11/11/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/11/2014

Labeler - CVS (062312574)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(59779-230) , label(59779-230)