Label: CLEAR ACNE KIT- acne kit kit
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Contains inactivated NDC Code(s)
NDC Code(s): 50718-0031-1, 50718-0032-1, 50718-0033-1, 50718-0034-1 - Packager: Kamedis
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 6, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.
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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
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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
- Carton Label
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INGREDIENTS AND APPEARANCE
CLEAR ACNE KIT
acne kit kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50718-0034 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50718-0034-1 1 in 1 CARTON 01/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 100 mL Part 2 1 BOTTLE 22 mL Part 3 1 BOTTLE 50 mL Part 1 of 3 CLEAR ACNE FACE CLEANSER
acne face cleanser liquidProduct Information Item Code (Source) NDC:50718-0031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 14.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) PURSLANE (UNII: M6S840WXG5) CHLORPHENESIN (UNII: I670DAL4SZ) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM HYDROXIDE (UNII: 55X04QC32I) SQUALANE (UNII: GW89575KF9) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) COCO MONOETHANOLAMIDE (UNII: C80684146D) LAUROYL LYSINE (UNII: 113171Q70B) MYRISTIC ACID (UNII: 0I3V7S25AW) SODIUM CHLORIDE (UNII: 451W47IQ8X) SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y) SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE SODIUM (UNII: MP1J8420LU) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) SODIUM COCOYL APPLE AMINO ACIDS (UNII: EB3U1PA61T) METHYL GLUCOSE (UNII: QCF122NF3R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50718-0031-1 1 in 1 CARTON 1 100 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2018 Part 2 of 3 CLEAR ACNE SPOT TREATMENT
acne spot treatment liquidProduct Information Item Code (Source) NDC:50718-0032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 28.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) ALCOHOL (UNII: 3K9958V90M) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) BENZYL ALCOHOL (UNII: LKG8494WBH) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) CHLORPHENESIN (UNII: I670DAL4SZ) CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L) PURSLANE (UNII: M6S840WXG5) GLYCERIN (UNII: PDC6A3C0OX) RHEUM PALMATUM ROOT (UNII: G025DAL7CE) SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X) PICEA ABIES WOOD (UNII: 72GZ8K8996) PROPANEDIOL (UNII: 5965N8W85T) SARCOSINE (UNII: Z711V88R5F) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) TROMETHAMINE (UNII: 023C2WHX2V) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) CINNAMON BARK OIL (UNII: XE54U569EC) HEXYLENE GLYCOL (UNII: KEH0A3F75J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50718-0032-1 1 in 1 CARTON 1 22 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2018 Part 3 of 3 CLEAR ACNE FACE MOISTURIZER
acne face moisturizer lotionProduct Information Item Code (Source) NDC:50718-0033 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 28.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ALCOHOL (UNII: 3K9958V90M) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) BENZYL ALCOHOL (UNII: LKG8494WBH) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) CETYL ALCOHOL (UNII: 936JST6JCN) PURSLANE (UNII: M6S840WXG5) CHLORPHENESIN (UNII: I670DAL4SZ) RHEUM PALMATUM ROOT (UNII: G025DAL7CE) CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PICEA ABIES WOOD (UNII: 72GZ8K8996) PROPANEDIOL (UNII: 5965N8W85T) SARCOSINE (UNII: Z711V88R5F) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) CINNAMON BARK OIL (UNII: XE54U569EC) SHEA BUTTER (UNII: K49155WL9Y) SODIUM HYDROXIDE (UNII: 55X04QC32I) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) SQUALANE (UNII: GW89575KF9) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DOCOSANOL (UNII: 9G1OE216XY) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) NORI (UNII: 477TV3P5UX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50718-0033-1 1 in 1 CARTON 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2018 Labeler - Kamedis (080311300) Establishment Name Address ID/FEI Business Operations Biogenesis Inc. 069117328 manufacture(50718-0034)