Label: MAXIMUM STRENGTH ACNE SPOT TREATMENT CVS HEALTH- benzoyl peroxide 10% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-674-01 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 5, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
Do not use • if you have very sensitive
skin or are sensitive to benzoyl peroxide
When using this product • skin irritation
and dryness is more likely to occur if you
use another topical acne medication at
the same time. If irritation occurs, only
use one topical acne medication at a time.
• rinse right away with water if it gets in
eyes • avoid unnecessary sun exposure
and use a sunscreen • avoid contact with
the eyes, lips, and 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 use and ask a doctor if skin
irritation becomes severe - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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 product to
dry, then follow direction in the sunscreen
labeling. If sensitivity develops, discontinue
use of both products and consult a doctor. - INACTIVE INGREDIENT
- Questions?855-543-3784
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH ACNE SPOT TREATMENT CVS HEALTH
benzoyl peroxide 10% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-674 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide 10 g in 100 g Inactive Ingredients Ingredient Name Strength Aluminum Hydroxide (UNII: 5QB0T2IUN0) Bentonite (UNII: A3N5ZCN45C) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Isopropyl Myristate (UNII: 0RE8K4LNJS) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) Potassium Hydroxide (UNII: WZH3C48M4T) Potassium Sorbate (UNII: 1VPU26JZZ4) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-674-01 28 g in 1 TUBE; Type 0: Not a Combination Product 08/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/15/2018 Labeler - CVS (062312574) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(69842-674) , label(69842-674)