CLEARGENIX ADVANCED ACNE TREATMENT- benzoyl peroxide cream

Cleargenix Advanced Acne Treatment by

Drug Labeling and Warnings

Cleargenix Advanced Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Push Interactive, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient:

Benzoyl Peroxide 5.00%

Acne Treatment

Use For:

For the treatment of Acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

• *For external use only.
• *Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
• *Becauese 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 per day.

Do not use

for prolonged periods without consulting a doctor.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

• Store at room temperature.

Directions:

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. * For best results apply one to three times per day.

Other Ingredients:

Allantoin, Aloe Barbadensis (Organic Aloe Vera) Leaf Juice, Benzyl Alcohol, Betula Alba (Birch) Leaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Citrus Aurantium Dulcis (Orange/Neroli) Fruit Extract, Citrus Medica Limonum (Lemon) Peel Oil, DMDM Hydantoin, Fragrance (Parfum), Glycerin, Hamamelis Virginiana (Witch Hazel), Honey, Iodopropynyl Butylcarbamate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylpropanediol, Salix Alba (Willow) Bark Extract, Salvia Officinalis (Sage) Leaf Extract, Sodium Citrate, Sodium Hydroxide, Sugar Cane Extract, Vaccinium Myrtillus (Bilberry) Extract, Water (Aqua), Xanthan Gum.

Distributed by:

Cleargenis  225 thomas Ave N. Minneapolis, MN 55405  info@cleargenix.com

Package Labeling:

INGREDIENTS AND APPEARANCE

CLEARGENIX ADVANCED ACNE TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71817-858
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ORANGE (UNII: 5EVU04N5QU)
LEMON OIL (UNII: I9GRO824LL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
WITCH HAZEL (UNII: 101I4J0U34)
HONEY (UNII: Y9H1V576FH)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TEA TREE OIL (UNII: VIF565UC2G)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SALIX ALBA BARK (UNII: 205MXS71H7)
SAGE (UNII: 065C5D077J)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUGARCANE (UNII: 81H2R5AOH3)
BILBERRY (UNII: 9P2U39H18W)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71817-858-00	60 mL in 1 JAR; Type 0: Not a Combination Product	10/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/24/2017

Labeler - Push Interactive, LLC (031405563)