ACNE SPOT CORRECTOR

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 5g in 100mL
Labeler: DR LIN SKINCARE
NDC Code: 58876-103

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.

ACTIVE INGREDIENT

BENZYL PEROXIDE 5%

PURPOSE

ACNE TREATMENT

USE

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

WARNINGS

FOR EXTERNAL USE ONLY

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 THIS MEDICATION IF YOU

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

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 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 AND ASK A DOCTOR IF IRRITATION BECOMES SEVERE.

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

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 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 OR COMMENTS?

1-877-445-4624

MON-FRI 8AM - 5PM (PST)

ACNE SPOT CORRECTOR 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58876-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLYACRYLAMIDE (1500 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
CALENDULA OFFICINALIS WHOLE 
ARBUTIN 
KOJIC ACID 
ASCORBIC ACID 
SODIUM PYRROLIDONE CARBOXYLATE 
ALLANTOIN 
PANTHENOL 
HYALURONATE SODIUM 
CALENDULOSIDE E 
PHENOXYETHANOL 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:58876-103-3130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/13/2013
Labeler - DR LIN SKINCARE (622329980)
Establishment
NameAddressID/FEIOperations
Westwood Laboratories Inc.069926483manufacture(58876-103), pack(58876-103)

Revised: 06/2013
 
DR LIN SKINCARE

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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