BURN RELIEF CVS- lidocaine 4% liquid

Burn Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                         Purpose
Lidocaine 4%................................................................External analgesic

PURPOSE

Uses

 Temporarily relieves pain and itching due to: sunburn minor burns minor cuts scrapes insect bites minor skin irritations

WarningsFor 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 120ºF.
Stop use and ask doctor if
condition gets worse symptoms last more than 7 days
symptoms clear up and occur again in a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF  CVS
lidocaine 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	Lidocaine	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-050-05	133 mL in 1 CAN; Type 0: Not a Combination Product	02/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/16/2017

Labeler - CVS (062312574)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(69842-050)