Clear Acne Kit

Manufacturer
Kamedis | Biogenesis Inc.
Effective date
2020-07-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:20:30

Label at a glance#

ProductClear Acne Kit
Active ingredientSALICYLIC ACID
Label structure5 sections

Label contents#

Full prescribing information#

Step 1 - Acne Face CleanserDrug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If irritation persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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.

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-626-6606

Step 2 - Acne Spot TreatmentDrug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If irritation persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-626-6606

Step 3 - Acne Face MoisturizerDrug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If irritation persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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.

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-626-6606

SPL UNCLASSIFIED SECTION

Made in USA
Manufactured for Kamedis, New Jersey 07601
1-855-626-6606

www.kamedis-usa.com

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2200082{1 (22 ML) (salicylic acid 0.02 MG/MG Topical Gel) / 1 (100 ML) (salicylic acid 10 MG/ML Medicated Liquid Soap) / 1 (50 ML) (salicylic acid 20 MG/ML Topical Lotion) } PackGPCK2
1038982salicylic acid 1 % Medicated Liquid SoapPSN2
2200082salicylic acid 1 % Medicated Liquid Soap (100 ML) / salicylic acid 2 % Topical Lotion (50 ML) / salicylic acid 2 % Topical Gel (22 ML) PackPSN2
346298salicylic acid 2 % Topical GelPSN2
103568salicylic acid 2 % Topical LotionPSN2
346298salicylic acid 0.02 MG/MG Topical GelSCD2
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD2
103568salicylic acid 20 MG/ML Topical LotionSCD2
1038982salicylic acid 1 % Medicated Liquid SoapSY2
2200082salicylic acid 1 % Medicated Liquid Soap (100 ML) / salicylic acid 2 % Topical Lotion (50 ML) / salicylic acid 2 % Topical Gel (22 ML) PackSY2
346298salicylic acid 2 % Topical GelSY2
103568salicylic acid 2 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0034-12024-01-30C16284748780-11030e365-1bf2-111a-e063-dadaa90a10e2Clear Acne Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0031-1Clear Acne Kit1 in 1 CARTONLIQUID14.4 mg in 1mL2
50718-0031-1Clear Acne Kit100 mL in 1 BOTTLELIQUID100 mL14.4 mg in 1mL2
50718-0032-1Clear Acne Kit1 in 1 CARTONLIQUID28.8 mg in 1mL2
50718-0032-1Clear Acne Kit22 mL in 1 BOTTLELIQUID22 mL28.8 mg in 1mL2
50718-0033-1Clear Acne Kit50 mL in 1 BOTTLELOTION50 mL28.8 mg in 1mL2
50718-0033-1Clear Acne Kit1 in 1 CARTONLOTION28.8 mg in 1mL2
50718-0034-1Clear Acne Kit1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0031CLEAR ACNE KIT (ACNE KIT) KIT [KAMEDIS]2Current NDC, Legacy NDC20200708_de311f9e-a8e6-4a3e-ada0-b3882bb67b6c.zip
50718-0032CLEAR ACNE KIT (ACNE KIT) KIT [KAMEDIS]2Current NDC, Legacy NDC20200708_de311f9e-a8e6-4a3e-ada0-b3882bb67b6c.zip
50718-0033CLEAR ACNE KIT (ACNE KIT) KIT [KAMEDIS]2Current NDC, Legacy NDC20200708_de311f9e-a8e6-4a3e-ada0-b3882bb67b6c.zip
50718-0034CLEAR ACNE KIT (ACNE KIT) KIT [KAMEDIS]2Legacy NDC, 7 package rows20200708_de311f9e-a8e6-4a3e-ada0-b3882bb67b6c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 81 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Acne Face CleanserACNE FACE CLEANSERKamedis354e2f5b-021b-4683-abe3-7517faf6f7342024-02-07WarningsExact identifier
ndc (package): 50718-0031-1
ndc (product): 50718-0031
ndc11 (package): 50718003101
Clear Acne Spot TreatmentACNE SPOT TREATMENTKamedis00764a10-f1fe-45f5-89b4-9e891a2210042024-02-07WarningsExact identifier
ndc (package): 50718-0032-1
ndc (product): 50718-0032
ndc11 (package): 50718003201
Clear Acne Face MoisturizerACNE FACE MOISTURIZERKamedisb9304cde-1778-40c7-889f-f7647820f44f2024-02-07WarningsExact identifier
ndc (package): 50718-0033-1
ndc (product): 50718-0033
ndc11 (package): 50718003301
e7bccfa8-a499-4c08-b19c-45852b948b18de311f9e-a8e6-4a3e-ada0-b3882bb67b6c2020-07-06WarningsExact identifier
spl id: e7bccfa8-a499-4c08-b19c-45852b948b18
spl set id: de311f9e-a8e6-4a3e-ada0-b3882bb67b6c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.