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NDC 63824-0438-01 Clearasil Stubborn Acne Control 5in1 Spot Treatment 10 g/100g Details
Clearasil Stubborn Acne Control 5in1 Spot Treatment 10 g/100g
Clearasil Stubborn Acne Control 5in1 Spot Treatment is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 63824-0438-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 63824-0438 |
|---|---|
| Product ID | 63824-438_7ea592e7-4a0d-4a2a-8ac5-036a5ba14ac8 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Clearasil Stubborn Acne Control 5in1 Spot Treatment |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzoyl Peroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | g/100g |
| Substance Name | BENZOYL PEROXIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333D |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63824-0438-01 (63824043801)
| NDC Package Code | 63824-438-01 |
|---|---|
| Billing NDC | 63824043801 |
| Package | 1 TUBE in 1 CARTON (63824-438-01) / 28 g in 1 TUBE |
| Marketing Start Date | 2017-12-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL bdb87e60-67a6-4c0e-b0ab-3e238a08269c Details
Warnings
For external use only
When using this product
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
INGREDIENTS AND APPEARANCE
| CLEARASIL STUBBORN ACNE CONTROL 5IN1 SPOT TREATMENT
benzoyl peroxide cream |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 1/2022
Document Id: 7ea592e7-4a0d-4a2a-8ac5-036a5ba14ac8
Set id: bdb87e60-67a6-4c0e-b0ab-3e238a08269c
Version: 3
Effective Time: 20220121