CLEAROGEN 3- benzoyl peroxide lotion

CLEAROGEN 3 by

Drug Labeling and Warnings

CLEAROGEN 3 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzoyl Peroxide 2.5%

PURPOSE

Purpose- Acne Treatment

INDICATIONS & USAGE

Uses. For the treatment of acne

WARNINGS

Warning : For external use only

DO NOT USE

Avoid unnecessary sun exposure and use sunscreen.

WHEN USING

Avoid contact with eye, If product gets into eyes, rinse thoroughly with water.

STOP USE

If excessive irritation occurs reduce application to once a day. Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Direction:

After cleansing and toning apply lotion over the entire face. Use daily. If going outside use a sunscreen

Allow Clearogen to dry then follow directions in the sunscreen labeling. If irritation or sensitivity develops, discontinue use of all products, and consult a doctor.

OTHER SAFETY INFORMATION

Not applicable

INACTIVE INGREDIENT

Inactive Ingredient:

Aqua (Water), Linolenic Acid (Alpha & Gamma), Linoleic Acid,Glycerin, Glycine Soja (Soyabean) Sterols, Dodecyl Gallate, Octyl Ethylhexyl Gallate, Serenoa Serrulata Fruit Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol & Dicetyl Phosphate & Ceteth-10 Phosphate, Dimethicone, Aloe Barbadensis Leaf Extract, Glyceryl Stearate & PEG-100 Stearate, Sodium Hyaluronate, Cetyl Alcohol, Caprylyl Glycol, Phenoxyethanol,Extract of Malva Sylvestris (Mallow), Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Imperata Cylindrica Root Extract, Stearic Acid, Symphytum Officinale Extract, Camellia Oleifera(Green Tea)Leaf Exact, Tocopherol, Plantago Ovata Seed Extract, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Melia Azadirachta Leaf Extract, Chamomilla Recutita Flower Exact, Xanthan Gum, Ethylhexyl glycerin, Sulfur, Disodium EDTA, Magnesium Aluminum Silicate, Hexylene Glycol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAROGEN 3 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PLANTAGO OVATA SEED (UNII: UD50RBY30F)
WATER (UNII: 059QF0KO0R)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PRIMULA VERIS (UNII: W6LFQ57E4M)
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
XANTHAN GUM (UNII: TTV12P4NEE)
VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)
COMFREY ROOT (UNII: M9VVZ08EKQ)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYL GALLATE (UNII: O14R793D1H)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
CHAMOMILE (UNII: FGL3685T2X)
SULFUR (UNII: 70FD1KFU70)
LINOLENIC ACID (UNII: 0RBV727H71)
DODECYL GALLATE (UNII: 45612DY463)
SAW PALMETTO (UNII: J7WWH9M8QS)
SOY STEROL (UNII: PL360EPO9J)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4238-1	55 g in 1 TUBE; Type 0: Not a Combination Product	12/06/2023
2	NDC: 62742-4238-2	30 g in 1 TUBE; Type 0: Not a Combination Product	12/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/06/2023

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4238)