Label: ACNE DEFENSE FACE WASH- salicylic acid liquid
- NDC Code(s): 61197-120-00
- Packager: Pacifica Beauty, LLC
- 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 February 8, 2023
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- Official Label (Printer Friendly)
- Active ingredient Purpose
- Use
- Warnings
- INDICATIONS & USAGE
- Keep out of reach of children
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Directions
Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. 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.
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Inactive ingredients:
Aqua, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Aloe Barbadensis Leaf Juice*, Glycerin, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract*, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Camellia Sinensis (White Tea) Leaf Extract*, Arnica Montana Flower Extract*, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Panthenol, Allantoin, Potassium Sorbate, Sodium Benzoate, Sodium PCA, Ethylhexylglycerin, Parfum**. *certified organic **our scent blend with natural and/or essential oils.
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- Acne Defense Face Wash Label
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INGREDIENTS AND APPEARANCE
ACNE DEFENSE FACE WASH
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) LAVENDER OIL (UNII: ZBP1YXW0H8) WHITE TEA (UNII: O0M3396E09) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) SAGE OIL (UNII: U27K0H1H2O) PEPPERMINT OIL (UNII: AV092KU4JH) ALLANTOIN (UNII: 344S277G0Z) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CUCUMBER FRUIT OIL (UNII: R81Y52NPCT) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) NIACINAMIDE (UNII: 25X51I8RD4) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-120-00 172 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/08/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 02/08/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Sun Deep Inc. 189788201 manufacture(61197-120)
