Label: SPOT ACNE TREATMENT- benzoyl peroxide 2.5% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-7784-01 - Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
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 May 4, 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 if you are sensitive to benzoyl peroxide.
Stop use and ask a doctor if irritation becomes severe.
When using this product:
■ avoid unnecessary sun exposure and use a sunscreen
■ using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin.
If this occurs, only one drug should be used
■ 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
■ keep away from eyes, lips and mouth
■ avoid contact with hair and dyed fabrics, which may be bleached by this product - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Cleanse skin thoroughly before applying. Cover entire affected area with a thin layer 1 to 3 times daily. Start
with one application daily, because excessive drying may occur. Then gradually increase to 2 or 3 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 medication to dry before application of
sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor. - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPOT ACNE TREATMENT
benzoyl peroxide 2.5% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7784 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength Bentonite (UNII: A3N5ZCN45C) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Ethylhexylglycerin (UNII: 147D247K3P) Glycerin (UNII: PDC6A3C0OX) Glyceryl Laurate (UNII: Y98611C087) Magnesium Aluminum Silicate (UNII: 6M3P64V0NC) Phenoxyethanol (UNII: HIE492ZZ3T) Polysorbate 20 (UNII: 7T1F30V5YH) Sodium Citrate (UNII: 1Q73Q2JULR) Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-7784-01 1 in 1 CARTON 10/23/2017 1 21 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/23/2017 Labeler - Walgreens (008965063) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(0363-7784) , label(0363-7784)