NANO CLEANSE- benzoyl peroxide cream 
Sunrider Manufacturing L.P.

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.

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Use for management of acne.

Directions: Use morning and night. Apply a dime-sized amount to damp skin and gently massage for 1 to 2 minutes. Rinse well with warm water and pat dry. If bothersome dryness or peeling occurs, reduce application to once a day.

Directions: Use morning and night. Apply a dime-sized amount to damp skin and gently massage for 1 to 2 minutes. Rinse well with warm water and pat dry. If bothersome dryness or peeling occurs, reduce application to once a day.

Stop use and ask a doctor if excessive irritation occurs.

Warning: For external use only

Do not use ▄ If you have very sensitive skin, or if your skin is sensitive to benzoyl peroxide In rare instances, may cause severe allergic reactions or irritations that can be potentially life threatening. Avoid using if you have had previous allergic or hypersensitivity reaction. Stop using if you develop hives or itching of the face or body and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips, or tongue, feel faint, or have difficulty breathing.

Using other topical acne medications at the same time or immediately following us of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless otherwise directed by a healthcare professional.

When using this product ▄ Avoid contact with the eyes. If contact does occur, rinse thoroughly with water. Keep away from lips and mouth. ▄ Avoid unnecessary sun exposure during use, and use a sunscreen with least a SPF of 15.

Keep out of reach of children. If shallowed, seek medical help and contact a Poison Control Center immediately.

Active Ingredients: Benzoyl Peroxide (5%)

Inactive Ingredients: Water, PEG-80 Glyceryl Cocoate, Butyrospermum Parkii (Shea) Butter, Stearic Acid, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Juglans Regia (Walnut) Shell Powder, Cocamidopropyl Betaine, Glyceryl Stearate, PEG-100 Stearate, Magnesium Aluminum Silicate, Xanthan Gum, Simmondsia Chinensis (Jojoba) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Persea Gratissima (Avocado) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Oenothera Biennis (Evening Primrose) Oil, Lavandula Angustifolia (Lavender) Oil, Zea Mays (Corn) Oil, Dimethylaminoethanol, Glycolic Acid, Azelaic Acid, Retinyl Palmitate, Tocopherol, Ascorbyl Palmitate, Allantoin, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Medicago Sativa (Alfalfa) Leaf Powder, Rosmarinus Officinalis (Rosemary) Leaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Algae Extract, Aloe Barbadensis Leaf Juice, Hordeum Distichon (Barley) Extract, Capsicum Frutescens (Cayenne Pepper) Extract, Allium Sativum (Garlic) Bulb Extract, Euterpe Oleracea Fruit Extract, Fagopyrum Esculentum (Buckwheat) Hulls Extract, Citrus Grandis (Grapefruit) Fruit Extract, Butylene Glycol, Fragranced

Other Information: This product may bleach hair or dyed fabrics.

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NANO CLEANSE 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PEG-80 GLYCERYL COCOATE (UNII: A7D04GUR0Z)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
JUGLANS REGIA SHELL (UNII: PJ10MT7VKA)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-100 STEARATE (UNII: YD01N1999R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
LINSEED OIL (UNII: 84XB4DV00W)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
ALLANTOIN (UNII: 344S277G0Z)  
TEA TREE OIL (UNII: VIF565UC2G)  
DEANOL BITARTRATE (UNII: D240J05W14)  
ALFALFA LEAF (UNII: HY3L927V6M)  
AZELAIC ACID (UNII: F2VW3D43YT)  
ROSEMARY (UNII: IJ67X351P9)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
BARLEY (UNII: 5PWM7YLI7R)  
TABASCO PEPPER (UNII: J1M3NA843L)  
GARLIC (UNII: V1V998DC17)  
ACAI (UNII: 46AM2VJ0AW)  
FAGOPYRUM ESCULENTUM (UNII: B10M69172N)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CORN OIL (UNII: 8470G57WFM)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
NORI (UNII: 477TV3P5UX)  
PUMMELO (UNII: ET1TN5W71X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62191-014-091 in 1 PACKAGE08/04/2015
1248 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/04/2015
Labeler - Sunrider Manufacturing L.P. (786951475)
Registrant - Sunrider Manufacturing L.P. (786951475)
Establishment
NameAddressID/FEIBusiness Operations
Sunrider Manufacturing L.P.786951475manufacture(62191-014)

Revised: 12/2017
 
Sunrider Manufacturing L.P.