Label: ACNE WARRIOR CLEARING ASTRINGENT- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61197-101-00 - 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 January 6, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer 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, Alcohol Denat., Glycerin, Sorbitol, Hamamelis Virginiana (Witch Hazel) Water, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract1, Aloe Barbadensis Leaf Juice1, Epilobium Angustifolium Flower/Leaf/Stem Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract1, Chamomilla Recutita (Matricaria) Flower Extract 1, Camellia Sinensis (White Tea) Leaf Extract1, Arnica Montana Flower Extract1, Spiraea Ulmaria (Meadowsweet) Extract, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Lens Esculenta (Lentil) Seed Extract, Sodium PCA, Dipotassium Glycyrrhizate, Parfum2.
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- PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label
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INGREDIENTS AND APPEARANCE
ACNE WARRIOR CLEARING ASTRINGENT
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-101 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) Alcohol (UNII: 3K9958V90M) Glycerin (UNII: PDC6A3C0OX) Sorbitol (UNII: 506T60A25R) Hamamelis Virginiana Top Water (UNII: NT00Y05A2V) Niacinamide (UNII: 25X51I8RD4) Cucumber (UNII: YY7C30VXJT) Aloe Vera Leaf (UNII: ZY81Z83H0X) Epilobium Angustifolium Flowering Top (UNII: 08H094218D) 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) Lentil (UNII: 6O38V6B52O) Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-101-00 236 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(61197-101)