BLEMFREE- salicylic acid lotion 
Equibal, 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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BlemFree

Drug Facts Active Ingredient

Salicylic Acid 0.5% w/w

Purpose

Management of 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.

Uses

Acne

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

conjunction with other products containing acids or Benzoyl Peroxide. Do use harsh cleaning pads or brushes.

Directions

After using Blemfree™ Cleansing WashConcentrate and Toner & Balancer in the morning, smooth a thin layer of Blemfree™ All-Day Lotion on your face, neck, or back. Start with one application daily, then increase to two times daily if needed or as  directed by a doctor.

Inactive Ingredients

Behentrimonium Methosulfate, Benzethonium Chloride, Bisabolol, Butylene Glycol, Cetyl Alcohol, Chamomilla (Metricarla Recutia) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

BlemFree Product Label

BLEMFREE.COM

EQUIBAL LABS, INC. ●1 (800) 247-2405

PATENT# 7,078,050

4 OZ. 118ML

Blemfree ™

A NATURAL APPROACH TO FIGHT ACNE

This patented antibacterial lotion protects our skin all while fighting bacteria. The astringent formula breaks down excess oils without causing redness or excessive dryness.

DRUG FACTS Use(s): Management of acne

Active Ingredient                     Purpose

Salicylic Acid 0.5% w/w     Management of Acne

Warnings: For external use only.

Do not use more than one acne product at a time.

Ask doctor if pregnant or breastfeeding

When using 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 or Benzoyl Peroxide. Do use harsh cleaning pads or brushes.

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, Butylene Glycol, Cetyl Alcohol, Chamomilla (Metricarla Recutia) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

Directions: After using Blemfree™ Cleansing WashConcentrate and Toner & Balancer in the morning, smooth a thin layer of Blemfree™ All-Day Lotion on your face, neck, or back. Start with one application daily, then increase to two times daily if needed or as  directed by a doctor.

Equibal BlemFree Label

Blemfree™ ALL DAY LOTION        VISIT BLEMFREE.COM

                                                                For an explanation of our ingredients.

DRUG FACTS                      Use(s): Management of acne

Active Ingredient                 Purpose

Salicylic Acid 0.5% w/w                Management of Acne

Warnings: For external use only.

Do not use more than one acne product at a time.

Ask doctor if pregnant or breastfeeding

When using 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 or Benzoyl Peroxide. Do use harsh cleaning pads or brushes.

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, Butylene Glycol, Cetyl Alcohol, Chamomilla (Metricarla Recutia) Extract, Chlorhexidine Gluconate, Dimethicone, Mentha Spicata (Spearmint) Oil, Menthyl Lactate, Octyldodecanol, Phenoxyethanol, Polyquatemium-37, Rosemary (Rosmarinus Officinalis) Leaf Oil, Stearic Acid, Water (Aqua), Witch Hazel (Hamamelis Virginiana) Extract.

Questions or Comments? Call us toll free at 1(800)247-2405. Tuesday-Friday 8AM-6PM ET.

Equibal Labs®, PO Boix 180, Unionville, NY 10988. Retain this insert for directions and information.

Equibal BlemFree1 Label

Equibal BlemFree1 Label

BLEMFREE 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53228-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.587 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53228-002-01118 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/01/2014
Labeler - Equibal, Inc. (144679883)
Registrant - Equibal, Inc. (144679883)
Establishment
NameAddressID/FEIBusiness Operations
Equibal, Inc.144679883manufacture(53228-002)

Revised: 10/2022
 
Equibal, Inc.