84844-004 - DailyMed Details

84844-004

SPL v1

SPL

SPL Set ID 25bd4acc-a5fb-8f72-e063-6394a90ad876

Route

TOPICAL

Published

Effective Date 2024-11-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (2 g)

Inactive Ingredients

Lanolin Propyl Acetate Paraffin White Wax Glyceryl 2-caprylate Oleamide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-10-31

Description

Camphor 2%

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Description

Camphor 2%

Use

·Helps provide relief of symptoms of cold sores and dry lips.

Stop Use

if the condition worsens or symptoms last more than 7 days or clear up and occur again within a few days

Warnings

·For external use only. When using this product, keep out of eyes. Rinse with water to remove.

Ask Doctor

if the condition worsens or symptoms last more than 7 days or clear up and occur again within a few days

Directions

· Apply to lips not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Do Not Use

on deep puncture wounds, serious burns, or animal bites.

When Using

this product, keep out of eyes. Rinse with water to remove.

Active Ingredient

Camphor 2%

Other Information

This is a personal care item and should be used by one individual only.Inactive

Inactive Ingredients

·Beeswax white, GLYCERYL 2-CAPRYLATE，Lanolin, Oleamide, Paraffin,Propyl Acetate

Principal Display Panel

Keep Oot of Reach of Children

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

Structured Label Content

Use

·Helps provide relief of symptoms of cold sores and dry lips.

Purpose

External Analgesic

Stop Use

if the condition worsens or symptoms last more than 7 days or clear up and occur again within a few days

Warnings

·For external use only. When using this product, keep out of eyes. Rinse with water to remove.

Ask Doctor

if the condition worsens or symptoms last more than 7 days or clear up and occur again within a few days

Directions

· Apply to lips not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

Do Not Use (Do not use)

on deep puncture wounds, serious burns, or animal bites.

When Using

this product, keep out of eyes. Rinse with water to remove.

Active Ingredient

Camphor 2%

Other Information (Other information)

This is a personal care item and should be used by one individual only.Inactive

Inactive Ingredients (Inactive ingredients)

·Beeswax white, GLYCERYL 2-CAPRYLATE，Lanolin, Oleamide, Paraffin,Propyl Acetate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

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

Advanced Ingredient Data

[{"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL ACETATE", "unii": "4AWM8C91G6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL 2-CAPRYLATE", "unii": "O8TCW8DUW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLEAMIDE", "unii": "7L25QK8BWO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "·Helps provide relief of symptoms of cold sores and dry lips.", "Purpose": "External Analgesic", "Stop Use": "if the condition worsens or symptoms last more than 7 days or clear up and occur again within a few days", "Warnings": "·For external use only. When using this product, keep out of eyes. Rinse with water to remove.", "Ask Doctor": "if the condition worsens or symptoms last more than 7 days or clear up and occur again within a few days", "Directions": "· Apply to lips not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.", "Do not use": "on deep puncture wounds, serious burns, or animal bites.", "When Using": "this product, keep out of eyes. Rinse with water to remove.", "Active Ingredient": "Camphor 2%", "Other information": "This is a personal care item and should be used by one individual only.Inactive", "Inactive ingredients": "·Beeswax white, GLYCERYL 2-CAPRYLATE，Lanolin, Oleamide, Paraffin,Propyl Acetate", "Keep Oot Of Reach Of Children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:12.615956 · Updated: 2026-03-14T23:04:46.577979