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NDC 72644-0636-01 Spot On Treatment 10 g/100g Details
Spot On Treatment 10 g/100g
Spot On Treatment is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by SGII, INC. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 72644-0636-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 72644-0636 |
|---|---|
| Product ID | 72644-636_d2948dc8-0769-7dcc-e053-2995a90a10d9 |
| 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 | Spot On Treatment |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzyl Peroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | g/100g |
| Substance Name | BENZOYL PEROXIDE |
| Labeler Name | SGII, INC |
| 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 72644-0636-01 (72644063601)
| NDC Package Code | 72644-636-01 |
|---|---|
| Billing NDC | 72644063601 |
| Package | 15 g in 1 BOTTLE (72644-636-01) |
| Marketing Start Date | 2020-09-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL af7500db-4445-36f6-e053-2995a90a8754 Details
SPL UNCLASSIFIED SECTION
When using 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. • 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 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
Inactive Ingredients
Allantoin, Aloe Vera (Aloe Barbadensis) Leaf Juice, Bisabolol, Caprylyl Glycol, Carbomer, C13-14 Isoalkane, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Dimethyl Isosorbide, Ethylhexylglycerin, Ginger (Zingiber Officinale) Root Extract, Hexylene Glycol, Laureth-7, Menthoxypropanediol, Panthenol, PEG-40 Stearate, Phenoxyethanol, Polyacrylamide, Propanediol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Water/Aqua/Eau, Xanthan Gum.
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| SPOT ON TREATMENT
benzyl peroxide lotion |
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| Labeler - SGII, INC (070096792) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| 220 LABORATORIES INC | 783247950 | manufacture(72644-636) | |