CLEAR ACNE KIT- acne kit kit

Clear Acne Kit by

Drug Labeling and Warnings

Clear Acne Kit by is a Otc medication manufactured, distributed, or labeled by Kamedis, Biogenesis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Step 1 - Acne Face CleanserDrug Facts

Active Ingredient

Salicylic acid 1.0%

Purpose

Acne Treatment

Use

• For the treatment of acne

Warnings

For external use only

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.

Stop use and ask a doctor

• If irritation persists

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.

Questions or Comments?

1-855-626-6606

Step 2 - Acne Spot TreatmentDrug Facts

Active Ingredient

Salicylic acid 2.0%

Purpose

Acne Treatment

Use

• For the treatment of acne

Warnings

For external use only

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.

Stop use and ask a doctor

• If irritation persists

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

Questions or Comments?

1-855-626-6606

Step 3 - Acne Face MoisturizerDrug Facts

Active Ingredient

Salicylic acid 2.0%

Purpose

Acne Treatment

Use

• For the treatment of acne

Warnings

For external use only

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.

Stop use and ask a doctor

• If irritation persists

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.

Questions or Comments?

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

INGREDIENTS AND APPEARANCE

CLEAR ACNE KIT 
acne kit kit

Product 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 liquid

Product 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 liquid

Product 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 lotion

Product 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 (533176319)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(50718-0034)