LIDOCAINE- burn relief aerosol, spray
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dollar General - Rexall - Burn Relief Spray

Active Ingredients

Lidocaine 0.5%

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with:

sunburn
minor burns
minor cuts
scrapes
insect bites
minor skin irritations

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

do not get into eyes
ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

condition gets worse
symptoms last more than 7 days or clears up and occurs 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 can well
for adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily
for children under 2 years of age, ask a doctor
to apply to face spray in palm of hand and gently apply

Other information

store between 20º and 25ºC (68º and 77ºF)

Inactive ingredients

aloe barbadensis gel, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerine, methylparaben, propane, propylene glycol, propylparaben, tocopheryl acetate (vitamin E acetate), triethanolamine, simethicone, water

Questions?

Call 1-888-423-0139

Principal Display Panel

Rexall
Burn Relief Spray
Lidocaine 0.5%
External Analgesic

Relieves pain with lidocaine
Cools, moistures, soothes sunburn
Relieves insect bites & minor burns

NET WT 4.5 OZ (127 g)

Dollar General - Rexall Burn Relief Spray

LIDOCAINE
burn relief aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-840
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.64 g in 127 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTANE (UNII: 6LV4FOR43R)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPANE (UNII: T75W9911L6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55910-840-45	127 g in 1 CAN; Type 0: Not a Combination Product	05/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/08/2017

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 1/2023

Document Id: f27b1c16-e5c6-a72a-e053-2a95a90ac17c

Set id: 0383fcb8-8830-4cbf-a860-8a6b790a6dd1

Version: 5

Effective Time: 20230117

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)