PHACE BIOACTIVE CLARIFYING SERUM- salicylic acid cream

PHACE BIOACTIVE CLARIFYING SERUM by

Drug Labeling and Warnings

PHACE BIOACTIVE CLARIFYING SERUM by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

PHACE BIOACTIVE CLARIFYING SERUM 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-683
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-683-01	1 in 1 CARTON	02/10/2017
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/13/2016

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-683)