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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

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.

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 Juice1, Hydroxyethylcellulose, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract1, Spiraea Ulmaria (Meadowsweet) Extract, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Lens Esculenta (Lentil) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract1, Chamomilla Recutita (Matricaria) Flower Extract1, Camellia Sinensis (White Tea) Leaf Extract1, Arnica Montana Flower Extract1, Dipotassium Glycyrrhizate, Parfum2.

1 certified organic

2 our scent blend with natural and/or essential oils

Questions or comments?

Call toll free 1-888-322-2466

Pacifica Beauty LLC Portland, Oregon

PRINCIPAL DISPLAY PANEL - 29 ML Tube Carton

PACIFICA®

DRY IT
OUT
ACNE GEL
SPOT TREATMENT

maximum strength
2% salicylic acid
acne medication
+
niacinamide

100% VEGAN
CRUELTY-FREE

1 FL OZ 29 ML

INGREDIENTS AND APPEARANCE

DRY IT OUT ACNE SPOT TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61197-102
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)
Hamamelis Virginiana Top (UNII: UDA30A2JJY)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Niacinamide (UNII: 25X51I8RD4)
Cucumber (UNII: YY7C30VXJT)
Sage Oil (UNII: U27K0H1H2O)
Peppermint Oil (UNII: AV092KU4JH)
Lens Culinaris Fruit (UNII: ZYZ076G9JH)
Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P)
Chamomile (UNII: FGL3685T2X)
White Tea (UNII: O0M3396E09)
Arnica Montana Flower (UNII: OZ0E5Y15PZ)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61197-102-00	1 in 1 CARTON	02/01/2019
1		29 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	02/01/2019

Labeler - Pacifica Beauty LLC. (058549421)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	MANUFACTURE(61197-102)