OCEAN SEAS DERMATOLOGY ACNE TREATMENT CLEANSER- benzoyl peroxide solution 
Coastal Carolinas Integrated Medicine

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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Ocean Seas Dermatology Acne Treatment Cleanser

Active ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Uses

for treatment of acne

Warnings

For external use only

Do Not Use

• if you have very sensitive skin • are sensitive to benzoyl peroxide.

When Using This Product

• avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

Stop and Ask a Doctor

• if irritation becomes severe.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use every evening. Wet face with water. Apply a dime-sized amount into hands and gently wash your face; take care to avoid the eye area. Rinse well. • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of product and ask a doctor.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, * Camellia Sinensis (Green Tea) Leaf Extract, * Fragrance, Ginkgo Biloba (Ginkgo) Leaf Extract, * Glycerin, * Glycerin* (and) Cucumis Sativus (Cucumber) Fruit Extract, * Morus Alba (Mulberry) Bark Extract, * Sodium C14-16 Alpha Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol (and) Methylisothiazolinone, Water. *organic

Questions or Comments

1-844-88OCEAN (6-2326)

Package/Label Principal Display Panel

OCEAN SEAS™
DERMATOLOGY

ACNE
TREATMENT
CLEANSER

Distributed by OCEAN SEAS DERMATOLOGY
North Myrtle Beach, SC 29597

Label

Label

OCEAN SEAS DERMATOLOGY ACNE TREATMENT CLEANSER 
benzoyl peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69627-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CUCUMBER (UNII: YY7C30VXJT)  
GINKGO (UNII: 19FUJ2C58T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MORUS ALBA BARK (UNII: 7O71A48NDP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69627-112-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/29/2016
Labeler - Coastal Carolinas Integrated Medicine (007485606)
Registrant - Coastal Carolinas Integrated Medicine (007485606)
Establishment
NameAddressID/FEIBusiness Operations
Dr. J SkinClinic, Inc.101497332MANUFACTURE(69627-112) , ANALYSIS(69627-112) , LABEL(69627-112)

Revised: 3/2016
Document Id: d11cde63-2276-4fc7-ad87-e696d3aa7a22
Set id: d11cde63-2276-4fc7-ad87-e696d3aa7a22
Version: 1
Effective Time: 20160328
 
Coastal Carolinas Integrated Medicine