Blem Free

Blem Free
SPL v15
SPL
SPL Set ID d6720efc-dbbe-4304-bb31-972b506a08bf
Route
TOPICAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.587 g)
Inactive Ingredients
Butylene Glycol Cetyl Alcohol Behentrimonium Methosulfate Benzethonium Chloride Levomenol Chlorhexidine Gluconate Dimethicone Matricaria Recutita Menthyl Lactate, (-)- Octyldodecanol Phenoxyethanol Polyquaternium-37 (25000 Mpa.s) Stearic Acid Water Witch Hazel Hamamelis Virginiana Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17

Description

Salicylic Acid 0.5% w/w

Purpose

Management of Acne


Medication Information

Purpose

Management of Acne

Description

Salicylic Acid 0.5% w/w

Uses

Acne

Warnings

For external use only

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.

Ask A Doctor If

pregnant or breastfeeding

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 FACTSUse(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 ifpregnant or breastfeeding

When using product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness become severe.

Do not use in conjunctionwith 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.

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 ifpregnant or breastfeeding

When using product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness become severe.

Do not use in conjunctionwith 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 Box 180, Unionville, NY 10988. Retain this insert for directions and information.

Do Not Use in Conjunction

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

Drug Facts Active Ingredient

Salicylic Acid 0.5% w/w

Stop Use and Ask A Doctor If

irritation and redness become severe

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.

When Using This Product Do Not Get Into Eyes.

if contact occurs, rinse eyes thoroughly with water


Structured Label Content

Uses

Acne

Purpose

Management of Acne

Warnings

For external use only

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.

Ask A Doctor If (Ask a doctor if)

pregnant or breastfeeding

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 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 FACTSUse(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 ifpregnant or breastfeeding

When using product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness become severe.

Do not use in conjunctionwith 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.

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 ifpregnant or breastfeeding

When using product do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness become severe.

Do not use in conjunctionwith 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 Box 180, Unionville, NY 10988. Retain this insert for directions and information.

Do Not Use in Conjunction (Do not use in conjunction)

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

Drug Facts Active Ingredient

Salicylic Acid 0.5% w/w

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation and redness become severe

Keep Out of Reach of Children. (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.

When Using This Product Do Not Get Into Eyes. (When using this product do not get into eyes.)

if contact occurs, rinse eyes thoroughly with water


Advanced Ingredient Data


Raw Label Data

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