Label: BLEMFREE- salicylic acid lotion
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- NDC Code(s): 53228-002-01
- Packager: Equibal, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 22, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts Active Ingredient
- Purpose
- Keep out of reach of children.
- Uses
- Warnings
- Ask a doctor if
- When using this product do not get into eyes.
- Stop use and ask a doctor if
- Do not use in conjunction
- Directions
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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.
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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.
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.
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INGREDIENTS AND APPEARANCE
BLEMFREE
salicylic acid lotionProduct 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)