MEDICATED ACNE SHOWER- salicylic acid gel

MEDICATED ACNE SHOWER by

Drug Labeling and Warnings

MEDICATED ACNE SHOWER 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

SALICYLIC ACID 2%

PURPOSE

PURPOSE

ACNE TREATMENT

INDICATIONS & USAGE

USE

FOR THE TREATMENT OF ACNE

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

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

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

QUESTIONS OR COMMENTS? 1-877-445-4624

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDICATED ACNE SHOWER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58876-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58876-108-30	295 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(58876-108) , pack(58876-108)