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NDC 50718-0034-01 Clear Acne Kit Details
Clear Acne Kit
Clear Acne Kit is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Kamedis. The primary component is .
MedlinePlus Drug Summary
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.
Related Packages: 50718-0034-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical
Product Information
| NDC | 50718-0034 |
|---|---|
| Product ID | 50718-0034_e7bccfa8-a499-4c08-b19c-45852b948b18 |
| 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 | Clear Acne Kit |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acne kit |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Kamedis |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333D |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50718-0034-01 (50718003401)
| NDC Package Code | 50718-0034-1 |
|---|---|
| Billing NDC | 50718003401 |
| Package | 1 KIT in 1 CARTON (50718-0034-1) * 1 BOTTLE in 1 CARTON (50718-0032-1) / 22 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50718-0033-1) / 50 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50718-0031-1) / 100 mL in 1 BOTTLE |
| Marketing Start Date | 2018-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL de311f9e-a8e6-4a3e-ada0-b3882bb67b6c Details
Step 1 - Acne Face CleanserDrug Facts
When using this product
- Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
- 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 at a time should be used, unless otherwise directed by a doctor.
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Wet face. Apply to hands, add water and work into lather. Gently massage all over face avoiding eye area. Rinse thoroughly and pat dry. Good for daily use.
- 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
- For children under 10 years of age, consult your physician.
Inactive Ingredients
Benzyl Alcohol, Chlorphenesin, Cocamide MEA, Cocamidopropyl Betaine, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Hydrolyzed Jojoba Ester, Lauroyl Lysine, Methyl Glucose Caprate/ Caprylate/ Oleate, Myristic Acid, Propanediol, Salt (Sodium Chloride), Soapberry (Sapindus Mukurossi) Fruit Extract, Sodium Cocoyl Apple Amino Acids, Sodium Hydroxide, Sodium Lauroyl Methyl Isethionate, Sodium Methyl Cocoyl Taurate, Squalane, Stearic Acid, Tetrasodium EDTA, Trisodium Ethylenediamine Dissuccinate, Vitamin E (Tocopheryl Acetate), Water, Xanthan Gum.
Step 2 - Acne Spot TreatmentDrug Facts
When using this product
- Avoid unnecessary sun exposure and use sunscreen.
- Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
- 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 at a time should be used, unless otherwise directed by a doctor.
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Cleanse the skin thoroughly before applying medication.
- 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.
- For children under 10 years of age, consult your physician.
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Amur Cork Tree (Phellodendron Amurense) Bark Extract, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Benzyl Alcohol, Capryloyl Glycine, Chinese Rhubarb (Rheum Palmatum ) Root Extract, Chlorphenesin, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Fragrance, Glycerin, Great Burnet (Sanguisorba Officinalis) Root Extract, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Sodium Phytate, Tromethamine, Water, Xanthan Gum
Step 3 - Acne Face MoisturizerDrug Facts
When using this product
- Avoid unnecessary sun exposure and use sunscreen.
- Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
- 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 at a time should be used, unless otherwise directed by a doctor.
Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Cleanse the skin thoroughly before applying medication.
- 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.
- For children under 10 years of age, consult your physician.
Inactive Ingredients
Alcohol, Arachidyl Alcohol, Arachidyl Glucoside, Ascorbyl Tetraisopalmitate, Baikal Skullcap (Scutellaria Baicalensis) Root Extract, Behenyl Alcohol, Benzyl Alcohol, Capryloyl Glycine, Carbomer, Cetyl Alcohol, Chlorphenesin, Chinese Rhubarb (Rheum Palmatum) Root Extract, Chrysanthemum (Chrysanthemum Indicum) Flower Extract, Cinnamon (Cinnamomum Zeylanicum) Bark Extract, Common Purslane (Portulaca Oleracea) Extract, Dicaprylyl Carbonate, Fragrance, Glucose, Glycerin, Hexylene Glycol, Norway Spruce (Picea Abis) Extract, Phenethyl Alcohol, Plankton Extract, Propanediol, Sarcosine, SD Alcohol 40-C, Shea Butter (Butyrospermum Parkii), Sodium Hydroxide, Sodium Phytate, Squalane, Stearyl Alcohol, Water, Xanthan Gum.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| CLEAR ACNE KIT
acne kit kit |
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| Labeler - Kamedis (080311300) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Biogenesis Inc. | 069117328 | manufacture(50718-0034) | |