ACNE SPOT CORRECTOR MAXIMUM STRENGTH- benzoyl peroxide cream

ACNE SPOT CORRECTOR by

Drug Labeling and Warnings

ACNE SPOT CORRECTOR by is a Otc medication manufactured, distributed, or labeled by DR LIN SKINCARE, Westwood Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

BENZYL PEROXIDE 10%

PURPOSE

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE

USE

FOR THE TREATMENT OF ACNE AND ACNE DARK AND RED MARKS.

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

WHEN USING THIS PRODUCT

• AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
• AVOID CONTACT WTH 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, TCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUEBTLY OR IN A LOWER CONCENTRATION.

DO NOT USE

DO NOT USE THIS MEDICATION IF YOU

• HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE.

ASK DOCTOR/PHARMACIST

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

OTHER SAFETY INFORMATION

Other information

sensitivity test: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.

avoid contact with hair and dyed fabrics, which may be bleached by this product.

STOP USE

STOP USE AND ASK A DOCTOR IF IRRITATION BECOMES SEVERE.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DOSAGE & ADMINISTRATION

DIRECTIONS

• CLEANSE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT.
• APPLY A THIN LAYER DIRECTLY TO AFFECTED AREA ONE TO THREE TIMES DAILY.
• 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 CCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
• IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT.
• STORE AT 60°F - 90°F.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Water, Glycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Calendula Extract, Arbutin, Kojic Acid, Ascorbic Acid, Sodium PCA, Allantoin, Panthenol, Sodium Hyaluronate, Glycosphingolipids, Phenoxyethanol, Methylisothiazolinone, Fragrance

QUESTIONS

QUESTIONS OR COMMENTS?

1-877-445-4624

MON-FRI 8AM - 5PM (PST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE SPOT CORRECTOR  MAXIMUM STRENGTH
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58876-106
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
ARBUTIN (UNII: C5INA23HXF)
KOJIC ACID (UNII: 6K23F1TT52)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CALENDULOSIDE E (UNII: 184358RYCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58876-106-91	1 in 1 BOX
1	NDC: 58876-106-31	30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/13/2013

Labeler - DR LIN SKINCARE (622329980)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories Inc.		069926483	manufacture(58876-106) , pack(58876-106)