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PHACE BIOACTIVE CLARIFYING SERUM

Dosage form: cream
Ingredients: SALICYLIC ACID 15mg in 1mL
Labeler: Vara International Inc.
NDC Code: 70960-683

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.

PHACE BIOACTIVE CLARIFYING SERUM

Drug Facts


Active ingredients

Salicylic Acid 1.5%

Purpose

Acne Treatment

Uses
  • for the treatment of acne
  • reduces the number and severity of acne blemishes and allows skin to heal

Warnings

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.  Avoid eye contact.  If contact occurs, flush thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions
  • after cleansing, apply a thin layer to affected area 1-3 times daily.  If irritating dryness or peeling occurs, reduce application to once per day or every other day.

Inactive Ingredients

Aqua/Water/Eau, Arnica Montana Flower Extract, Capryloyl Salicylic Acid, Centella Asiatica Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Diisopropyl Adipate, Glycolic Acid, Hydroxyethylcellulose, Hydroxyethylpiperazine Ethane Sulfonic Acid, Methylisothizolinone, Octadedecenedioic Acid, Polysorbate 80, Alcohol Denat., Sodium Hydroxide, Propanediol, Zingiber Officinale (Ginger) Extract.

Other Information

Store in a cool, dark place.

Questions or comments?


Toll-free 1-800-942-1498 or visit www.phacebioactive.com

Sunburn Alert:

This product contains an alpha-hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn.  Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

PHACE BIOACTIVE CLARIFYING SERUM 30ml (65121-683-01)

PHACE BIOACTIVE CLARIFYING SERUM 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70960-683
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ARNICA MONTANA FLOWER 
CAPRYLOYL SALICYLIC ACID 
CENTELLA ASIATICA 
CITRIC ACID MONOHYDRATE 
CUCUMBER 
TURMERIC 
DIISOPROPYL ADIPATE 
GLYCOLIC ACID 
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID 
METHYLISOTHIAZOLINONE 
OCTADECENEDIOIC ACID 
POLYSORBATE 80 
SODIUM HYDROXIDE 
PROPANEDIOL 
GINGER 
Packaging
#Item CodePackage Description
1NDC:70960-683-011 BOTTLE, PUMP in 1 CARTON
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/13/2016
Labeler - Vara International Inc. (080371258)

Revised: 02/2017
 
Vara International Inc.

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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