Walgreens Aloe Vera Burn Relief Pain Relieving: Package Insert and Label Information

WALGREENS ALOE VERA BURN RELIEF PAIN RELIEVING- lidocaine hydrochloride gel
WALGREEN CO.

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.

Active Ingredient

Lidocaine HCl 0.50%

Purpose

Topical Analgesic

Uses

  • temporary pain relief
  • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites.

Warnings

For external use only

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

When using this product

  • avoid contact with eyes.

stop use and ask a doctor if

  • conditions worsens or symptoms persists for more than 7 days.
  • Symptoms clear up and occur again within a few days.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • 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: do not use, ask a doctor.

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.

Principal Display Panel

walgreens
ALOE VERA
BURN
RELIEF
PAIN RELIEVING GEL
with LIDOCAINE HCLHelps Relieve Pain from:
Sunburn
Minor Cuts and scrapes
Insect Bites
Minor Burns
NET WT 8 OZ. (226 g)
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ZWA028A0f.jpgZWA028A0b.jpg
WALGREENS ALOE VERA BURN RELIEF PAIN RELIEVING
lidocaine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
TROLAMINE
ISOPROPYL ALCOHOL
EDETATE DISODIUM
ALOE VERA LEAF
PROPYLENE GLYCOL
GLYCERIN
POLYSORBATE 80
DIAZOLIDINYL UREA
MENTHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-4000-16 226 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/04/2012
Labeler — WALGREEN CO. (008965063)

Revised: 12/2012 WALGREEN CO.

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