carmex classic lip balm medicated

carmex classic lip balm medicated
SPL v5
SPL
SPL Set ID fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57
Route
topical
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (synthetic) (1.7 g) white petrolatum (45.3 g)
Inactive Ingredients
lanolin cetyl esters wax cocoa butter paraffin yellow wax menthol salicylic acid phenol vanilla

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-09-26

Purpose

External Analgesic Lip Protectant

Description

Camphor 1.70% White Petrolatum 45.30%


Medication Information

Warnings

For external use only

Uses
  • helps provide relief of symptoms of cold sores and dry lips
Purpose

External Analgesic

Lip Protectant

Directions
  • apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Other Information
  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun
Inactive Ingredients

lanolin, cetyl esters, theobroma cacao seed butter, paraffin, beeswax, menthol, salicylic acid, phenol, vanillin, flavor

Description

Camphor 1.70% White Petrolatum 45.30%

Do Not Use On:

• deep puncture wounds • serious burns • animal bites

Package Labeling:

Active Ingredients

Camphor 1.70%

White Petrolatum 45.30%

When Using This Product:

keep out of eyes. Rinse with water to remove.

Package Labeling:10210 0022 7

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.

Package Labeling: 10210 0022 8


Structured Label Content

Warnings

For external use only

Uses
  • helps provide relief of symptoms of cold sores and dry lips
Purpose

External Analgesic

Lip Protectant

Directions
  • apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
Other Information
  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun
Inactive Ingredients

lanolin, cetyl esters, theobroma cacao seed butter, paraffin, beeswax, menthol, salicylic acid, phenol, vanillin, flavor

Do Not Use On: (Do not use on:)

• deep puncture wounds • serious burns • animal bites

Package Labeling:

Active Ingredients

Camphor 1.70%

White Petrolatum 45.30%

When Using This Product: (When using this product:)

keep out of eyes. Rinse with water to remove.

Package Labeling:10210 0022 7 (Package Labeling:10210-0022-7)

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.

Package Labeling: 10210 0022 8 (Package Labeling: 10210-0022-8)


Advanced Ingredient Data


Raw Label Data

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