Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d

Route

TOPICAL

Published

Effective Date 2023-05-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Glycerin (200 mg)

Inactive Ingredients

Hydroxyethyl Cellulose, Unspecified Menthol, Unspecified Form Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Trisodium Citrate Dihydrate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Glycerin 20% Lidocaine HCl 4%

Purpose

Lip Protectant External Analgesic

Medication Information

Purpose

Lip Protectant External Analgesic

Description

Glycerin 20% Lidocaine HCl 4%

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

Purposes

Lip Protectant

External Analgesic

Warnings

For external use only

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

Do Not Use

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

Other Information

store at 20-25 ^oC (68 ^o-77 ^oF)

Active Ingredients

Glycerin 20%

Lidocaine HCl 4%

Inactive Ingredients

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

propylparaben, trisodium citrate dihydrate, water

Additional Information

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

Do not use if carton is broken or damaged.

CARTON Recycle

Questions Or Comments?

1-877-709-3539

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

When Using This Product

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.

Structured Label Content

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

Purposes

Lip Protectant

External Analgesic

Warnings

For external use only

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

Do Not Use (Do not use)

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

Other Information (Other information)

store at 20-25 ^oC (68 ^o-77 ^oF)

Active Ingredients (Active ingredients)

Glycerin 20%

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

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

propylparaben, trisodium citrate dihydrate, water

Additional Information

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

Do not use if carton is broken or damaged.

CARTON Recycle

Questions Or Comments? (Questions or comments?)

1-877-709-3539

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

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "HYDROXYETHYL CELLULOSE, UNSPECIFIED", "unii": "T4V6TWG28D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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", "Purposes": "Lip Protectant External Analgesic", "Warnings": "For external use only", "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", "Do not use": "in large quantities, particularly over raw surfaces, or blistered areas", "Other information": "store at 20-25 o C (68 o -77 o F)", "Active ingredients": "Glycerin 20% Lidocaine HCl 4%", "Inactive ingredients": "edetate disodium, hydroxyethyl cellulose, menthol, methylparaben, polysorbate 80, propylene glycol, propylparaben, trisodium citrate dihydrate, water", "Additional Information": "Retain outer carton for full product uses, directions and warnings. Do not use if carton is broken or damaged. CARTON Recycle", "Questions or comments?": "1-877-709-3539", "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", "When using this product": "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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:11.016685 · Updated: 2026-03-14T23:03:06.131630