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MEDICATED ACNE SHOWER

Dosage form: gel
Ingredients: SALICYLIC ACID 2g in 100mL
Labeler: DR LIN SKINCARE
NDC Code: 58876-108

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

SALICYLIC ACID 2%

PURPOSE

ACNE TREATMENT

USE

FOR THE TREATMENT OF ACNE

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE IF YOU HAVE  KNOWN ALLERGY TO SALICYLIC ACID OR ASPERIN.

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 TH SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

STOP USE ND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

  • AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.

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

DIRECTIONS

  • USE MORNING AND NIGHT.
  • WET AREA TO BE CLEANSED.
  • APPLY ACNE TREATMENT ND GENTLY MASSAGE AREA FOR 1-2 MINUTES..
  • RINSE THOROUGHLY AND PAT DRY.
  • RINSE THOROUGHLY WITH WATER..

INACTIVE INGREDIENTS

WATER, SODIUM C14-16 OLEFIN SULFONATE, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM LAURYL SULFOACETATE, PEG-150 DISTEARATE, PHENOXYETHANOL, METHYLISOTHIAZOLINONE, AMINOMETHYL PROPANOL, SODIUM CHLORIDE, GLYCERIN, ALLANTOIN

QUESTIONS OR COMMENTS? 1-877-445-4624

MEDICATED ACNE SHOWER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58876-108
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM LAURYL SULFOACETATE 
PEG-150 DISTEARATE 
PHENOXYETHANOL 
METHYLISOTHIAZOLINONE 
AMINOMETHYLPROPANOL 
SODIUM CHLORIDE 
GLYCERIN 
ALLANTOIN 
Packaging
#Item CodePackage Description
1NDC:58876-108-30295 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(58876-108), pack(58876-108)

Revised: 07/2014
 
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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