SUNBURN RELIEF- lidocaine hcl 0.5% gel

Sunburn Relief by

Drug Labeling and Warnings

Sunburn Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Use

for the temporary relief of pain and itching associated with

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

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 the eyes

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or 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: ask a doctor

Inactive ingredients

water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5

ADVERSE REACTION

*This product is not manufactured or distributed by Bayer, distributer of Solarcaine ®Cool Aloe Burn Relief Formula

DISTRIBUTED BY: RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE:

If you're not satisfied, we'll happily refund your money.

Principal Panel Display

Compare to Salarcaine ®Cool Aloe Burn Relief Formula Pain Relieving Gel with Lidocaine HCI*

SUNBURN

RELIEF

PAIN RELIEVING GEL

WITH ALOE

Cools on contact

Great sunburn relief

Minor burn relief

NET WT 8 OZ (226 g)

Principal Panel Display

daylogic™

daylogic

FREE FROM PHTHALATES & PARABENS

sunburn relief gel

Pain Relieving Gel

WITH LIDOCAINE HCI

With Aloe Vera

Cools & Sooothes

Dermatologist Tested

NET WT 8 OZ (226g)

INGREDIENTS AND APPEARANCE

SUNBURN RELIEF 
lidocaine hcl 0.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0776
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0776-3	226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/30/2019

Labeler - Rite Aid Corporation (014578892)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(11822-0776)