BLEMFREE- salicylic acid lotion

BlemFree by

Drug Labeling and Warnings

BlemFree by is a Otc medication manufactured, distributed, or labeled by Equibal, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredient

Salicylic Acid 0.5% w/w

Purpose

Acne

Keep out of reach of children.

Keep out of reach of children

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

Use(s)

• acne
• fine lines
• discoloration
• large pores
• blackheads
  

Warnings

For external use only

Ask a doctor if

pregnant or breastfeeding

When using this product do not get into eyes.

if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

irritation and redness become severe

Do not use in conjunction

with other products containing acids

Directions

• cleanse with Blemfree Scrub and Beads. Rinse several times.
• apply Blemfree Toner.
• cover entire affected area with a thin layer of Blemfree All Day Lotion.
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Behentrimonium methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Chamomile (Matricaria recutita) Extract, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquarternium-37, Stearic Acid, Water, Witch Hazel (Hamamelis virginiana) Extract 

BlemFree Product Label

equibal labs®

BlemFree®
with finipil®

for acne

All Day Lotion

salicylic acid 0.5%

4 oz. 118 ml.

Drug Facts

Active Ingredient                             Purpose

Salicylic Acid 0.5% w/w ………….. Acne

Use(s)

acne fine lines discoloration large pores blackheads

Directions

cleanse with Blemfree Scrub & Beads, Rinse several times.

apply Blemfree Toner.

cover the entire affected area with a thin layer of Blemfree All Day Lotion.

because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Warnings

For external use only

Ask doctor if pregnant or breastfeeding

When using this product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation and redness become sever

Do not use in conjunction with other products containing acids

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Inactive Ingredients

Behentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butyleene Glycol, Cetyl Alcohol, Chlorhexidine Gluconate, Dimethicone, Chamomile (Matricaria recutita) Extract, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquarternium-37, Stearic Acid, Water, Witch Hazel (Hamamelis virginiana) Extract

equibal labs

800-247-2405
thebodyperfect.com   Made in USA

INGREDIENTS AND APPEARANCE

BLEMFREE 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53228-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.587 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
DIMETHICONE (UNII: 92RU3N3Y1O)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53228-002-01	118 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/01/2014

Labeler - Equibal, Inc. (144679883)

Registrant - Equibal, Inc. (144679883)

Establishment
Name	Address	ID/FEI	Business Operations
Equibal, Inc.		144679883	manufacture(53228-002)