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NDC 69842-0637-03 CVS Health Maximum Strength Acne Treatment 100 mg/mL Details
CVS Health Maximum Strength Acne Treatment 100 mg/mL
CVS Health Maximum Strength Acne Treatment is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 69842-0637-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 69842-0637 |
|---|---|
| Product ID | 69842-637_b238bebf-2797-4cc8-bdab-e9ada225f9f7 |
| 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 | CVS Health Maximum Strength Acne Treatment |
| Proprietary Name Suffix | Acne Medication |
| Non-Proprietary Name | Benzoyl Peroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/mL |
| Substance Name | BENZOYL PEROXIDE |
| Labeler Name | CVS Health |
| 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 69842-0637-03 (69842063703)
| NDC Package Code | 69842-637-03 |
|---|---|
| Billing NDC | 69842063703 |
| Package | 1 TUBE in 1 CARTON (69842-637-03) / 28 mL in 1 TUBE (69842-637-01) |
| Marketing Start Date | 2014-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b13e6c99-baa8-4e73-9572-3e0544f3b7f9 Details
Warnings
For external use only
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
When using this product
- keep away from eyes, lips and mouth
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
- using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Directions
- cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
INGREDIENTS AND APPEARANCE
| CVS HEALTH MAXIMUM STRENGTH ACNE TREATMENT
ACNE MEDICATION
benzoyl peroxide gel |
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| Labeler - CVS Health (062312574) |
| Registrant - Garcoa, Inc. (036464697) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Garcoa, Inc. | 036464697 | MANUFACTURE(69842-637) | |
Revised: 1/2022
Document Id: b238bebf-2797-4cc8-bdab-e9ada225f9f7
Set id: b13e6c99-baa8-4e73-9572-3e0544f3b7f9
Version: 2
Effective Time: 20220124