Label: DRY IT OUT ACNE SPOT TREATMENT- salicylic acid gel
- NDC Code(s): 61197-122-00
- 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 9, 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
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, Hamamelis Virginiana (Witch Hazel) Extract, Aloe Barbadensis Leaf Juice*, Hydroxyethylcellulose, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract*, Spiraea Ulmaria (Meadowsweet) Extract, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Lens Esculenta (Lentil) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Camellia Sinensis (White Tea) Leaf Extract*, Arnica Montana Flower Extract*, Dipotassium Glycyrrhizate, Parfum**. *certified organic **our scent blend with natural and/or essential oils
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- Dry It Out Acne Spot Treatment Label
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INGREDIENTS AND APPEARANCE
DRY IT OUT ACNE SPOT TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-122 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) NIACINAMIDE (UNII: 25X51I8RD4) LAVENDER OIL (UNII: ZBP1YXW0H8) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ALCOHOL (UNII: 3K9958V90M) HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) CUCUMBER FRUIT OIL (UNII: R81Y52NPCT) SAGE OIL (UNII: U27K0H1H2O) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) WATER (UNII: 059QF0KO0R) PEPPERMINT OIL (UNII: AV092KU4JH) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-122-00 29 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 02/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 02/09/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Sun Deep Inc. 189788201 manufacture(61197-122)
