DRY IT OUT ACNE SPOT TREATMENT- salicylic acid gel

Dry It Out Acne Spot Treatment by

Drug Labeling and Warnings

Dry It Out Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Pacifica Beauty, LLC, Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient Purpose

Salicylic Acid 2.0% Acne Medication

Use

For the treatment of acne.

Warnings

For external use only. Flammable: Keep away from fire or flame. 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.

INDICATIONS & USAGE

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.

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

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

Questions or comments?

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Pacifica Beauty LLC Portland, Oregon

Dry It Out Acne Spot Treatment Label

INGREDIENTS AND APPEARANCE

DRY IT OUT ACNE SPOT TREATMENT 
salicylic acid gel

Product 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)