Label: ACNE DEFENSE FACE WASH- salicylic acid liquid
- 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.
Updated January 6, 2020
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only.
When using this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- clean the skin thoroughly before applying this product
- 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.
Aqua, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Aloe Barbadensis Leaf Juice1, Glycerin, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract1, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract1, Chamomilla Recutita (Matricaria) Flower Extract1, Camellia Sinensis (White Tea) Leaf Extract1, Arnica Montana Flower Extract1, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Panthenol, Allantoin, Potassium Sorbate, Sodium Benzoate, Sodium PCA, Ethylhexylglycerin, Parfum2.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 172 ML Bottle Label
INGREDIENTS AND APPEARANCE
ACNE DEFENSE FACE WASH
salicylic acid liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Aloe Vera Leaf (UNII: ZY81Z83H0X) Glycerin (UNII: PDC6A3C0OX) Niacinamide (UNII: 25X51I8RD4) Cucumber (UNII: YY7C30VXJT) Lavandula angustifolia subsp. Angustifolia flowering top (UNII: 9YT4B71U8P) Chamomile (UNII: FGL3685T2X) White Tea (UNII: O0M3396E09) Arnica Montana Flower (UNII: OZ0E5Y15PZ) Sage Oil (UNII: U27K0H1H2O) Peppermint Oil (UNII: AV092KU4JH) Panthenol (UNII: WV9CM0O67Z) Allantoin (UNII: 344S277G0Z) Potassium Sorbate (UNII: 1VPU26JZZ4) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Ethylhexylglycerin (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-100-00 172 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 02/01/2020 Labeler - Pacifica Beauty LLC. (058549421) Establishment Name Address ID/FEI Business Operations Sun Deep Inc. 189788201 MANUFACTURE(61197-100)