ABREVA RAPID PAIN RELIEF- glycerin, lidocaine gel

ABREVA by

Drug Labeling and Warnings

ABREVA by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Glycerin 20%

Lidocaine HCl 4%

Purposes

Lip Protectant

External Analgesic

Uses

• for the temporary relief of pain and itching associated with cold sores and fever blisters
• Relieves dryness and softens cold sores and fever blisters
• Softens crust (scabs) associated with cold sores and fever blisters

Warnings

For external use only

Do not use

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

When using this product

1. do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last 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

• push and turn cap to open, close tightly after use
• wash hands before and after applying
• adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 12 years: consult a doctor

Other information

• store at 20-25 oC (68 o-77 oF)

Inactive ingredients

edetate disodium, hydroxyethyl cellulose, menthol, methylparaben, polysorbate 80, propylene glycol,

propylparaben, trisodium citrate dihydrate, water

Questions or comments?

1-877-709-3539

Additional Information

Retain outer carton for full product uses, directions and warnings.

Do not use if carton is broken or damaged.

CARTON Recycle

Principal Display Panel

abreva

RAPID

PAIN RELIEF

Cold Sore

MAX

STRENGTH

LIDOCAINE

For rapid numbing effect

Lidocaine HCl 4% / Glycerin 20%

External Analgesic / Lip Protectant

NET WT 3 g (0.10 oz)

PA 202119 – Front Panel

INGREDIENTS AND APPEARANCE

ABREVA   RAPID PAIN RELIEF
glycerin, lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0400-01	1 in 1 PACKAGE	06/01/2023
1		3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2023

Labeler - Haleon US Holdings LLC (079944263)