PHACE BIOACTIVE CLARIFYING SERUM- salicylic acid cream 
Vara International Inc.

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.

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PHACE BIOACTIVE CLARIFYING SERUM

Drug Facts


Active ingredients

Salicylic Acid 1.5%

Purpose

Acne Treatment

Uses

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

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)

Clarifying Serum Label

PHACE BIOACTIVE CLARIFYING SERUM 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70960-683
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CUCUMBER (UNII: YY7C30VXJT)  
TURMERIC (UNII: 856YO1Z64F)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPANEDIOL (UNII: 5965N8W85T)  
GINGER (UNII: C5529G5JPQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70960-683-011 in 1 CARTON09/13/2016
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/13/2016
Labeler - Vara International Inc. (080371258)

Revised: 2/2017
Document Id: 4830e546-7dbb-3fb5-e054-00144ff8d46c
Set id: 71bf8350-092f-4529-bb6d-2c1fde5d6690
Version: 3
Effective Time: 20170210
 
Vara International Inc.