Debachere Butt Balm After Play Care Multi Symptoms Relief

Debachere Butt Balm After Play Care Multi Symptoms Relief
SPL v1
SPL
SPL Set ID f469b446-58a0-4be3-884f-d622b9d074f8
Route
TOPICAL
Published
Effective Date 2025-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (50 mg) Benzalkonium (10 mg)
Inactive Ingredients
Aloe Vera Leaf Yellow Wax Cetyl Esters Wax Ethyl Vanillin Helianthus Annuus Flowering Top Lanolin Menthol Paraffin Petrolatum Salicylic Acid Cocoa Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-11
Description

Benzocaine 5.00% Benzalkonium Chloride 0.10%

Purpose

Topical Analgesic Antiseptic

Medication Information

Purpose

Topical Analgesic

Antiseptic

Description

Benzocaine 5.00% Benzalkonium Chloride 0.10%

Uses:
  • For the temporary relief of pains associated with burns, subrurn, minor cuts, scrapes, insect bites and minor skin irritations.
  • First aid help prevent infection in minor cuts, scrapes and burns.
Warnings:

For external use only, not intended for ingestion.

Directions
  • Clean the affected area.
  • 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: Consult a doctor.
Do Not Use
  • in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
Drug Facts

Package Labeling:

Active Ingredients

Benzocaine 5.00%

Benzalkonium Chloride 0.10%

Other Information:
  • Store at 20-25°C (60-77°F) and protect from moisture.
Inactive Ingredients

Aloe Extract, Beeswax, Campor, Cetty Esters, Ethyl Vanillin, Helianthus (sunflower) Oil, Lanolin, Menthol, Paraffin Wax, Petrolatum, Salicylic Acid, Theobroma Cacao(cocoa) Butter, FD&C Blue #1

When Using This Product
  • avoid contact with the eyes.
Stop Use and Ask A Doctor If
  • The condition persists or gets worse.

Do not use longer than 1 week unless directed by a doctor.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Uses:
  • For the temporary relief of pains associated with burns, subrurn, minor cuts, scrapes, insect bites and minor skin irritations.
  • First aid help prevent infection in minor cuts, scrapes and burns.
Purpose

Topical Analgesic

Antiseptic

Warnings:

For external use only, not intended for ingestion.

Directions
  • Clean the affected area.
  • 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: Consult a doctor.
Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Benzocaine 5.00%

Benzalkonium Chloride 0.10%

Other Information: (Other information:)
  • Store at 20-25°C (60-77°F) and protect from moisture.
Inactive Ingredients

Aloe Extract, Beeswax, Campor, Cetty Esters, Ethyl Vanillin, Helianthus (sunflower) Oil, Lanolin, Menthol, Paraffin Wax, Petrolatum, Salicylic Acid, Theobroma Cacao(cocoa) Butter, FD&C Blue #1

When Using This Product (When using this product)
  • avoid contact with the eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • The condition persists or gets worse.

Do not use longer than 1 week unless directed by a doctor.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:43.862133 · Updated: 2026-03-14T23:08:01.024401