NEUTRACURE RESTORE- benzoyl peroxide cream

NeutraCure Restore by

Drug Labeling and Warnings

NeutraCure Restore by is a Otc medication manufactured, distributed, or labeled by Neutracure. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Medication

Uses

• fot the treatment of acne
• use to prevent new pimples from forming

Warnings

For external use only

Do not use if

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

When using this product

• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips and mouth
• avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
• with other topical acne medications, at the same time ot immediately following use of this product. Increased dryness or imitation may occur. If this occurs, only one medication should be used unless directed by a doctor.
• skin imitation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate skin imitation. Mild imitation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor

if skin irritation becomes severe

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• cleanse the skin thoroughly before applying medication
• cover the entire affected area with a thin layer one to three times a day
• 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
• If going outside use a sunscreen. Allow Acne Treatment Cream to dry, then follow directions in sunscreen labeling . If sensitivity develops, discontinue use of both products and ask a doctor

Other Information

• keep tightly closed
• keep away from heat

Inactive ingredients:

ALLANTOIN, ALOE BARBADENSIS LEAF (ALOE VERA GEL) JUICE, BENZYL ALCOHOL, BETULA ALBA (BIRCH) EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CARBOMER, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) OIL, DMDM HYDANTOIN,
GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL), IODOPROPYNYL BUTYLCARBAMATE, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHOL,
METHYLISOTHIAZOLINONE, PARFUM (FRAGRANCE), POLYSORBATE-20, SACCHARUM OFFICINALIS (SUGAR) CANE EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, SALVIA OFFICINALIS (SAGE) EXTRACT, SODIUM CITRATE, SODIUM HYALURONATE (HYALURONIC ACID), SODIUM HYDROXIDE,
TRIETHANOLAMINE, VACCINIUM MYRTILLUS (BILBERRY) EXTRACT, XANTHAN GUM

Product Label

INGREDIENTS AND APPEARANCE

NEUTRACURE RESTORE 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69748-641
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)
ORANGE OIL (UNII: AKN3KSD11B)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
MENTHOL (UNII: L7T10EIP3A)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SALIX ALBA BARK (UNII: 205MXS71H7)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69748-641-01	59 mL in 1 JAR; Type 0: Not a Combination Product	02/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/10/2015

Labeler - Neutracure (079725043)