DERMA E ACNE BLEMISH CONTROL TREATMENT SERUM- salicylic acid liquid

Derma E Acne Blemish Control Treatment Serum by

Drug Labeling and Warnings

Derma E Acne Blemish Control Treatment Serum by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc., Topiderm, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Salicylic Acid 1.9%

Purpose

Anti-Acne

Uses

• For the treatment of acne
• Helps keep skin clear of new acne, acne blemishes, acne pimples and blackheads

Warnings

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.
• Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• SHAKE WELL
• 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.

Inactive ingredients

Purified Water, Glycerin, Hydroxypropyl Starch Phosphate (Sugar Starch), Salix Alba (Willow) Bark Extract, Epilobium Angustifolium (Canadian Willowherb) Extract, Aniba Rosodora (Rosewood) Wood Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), Organic Camellia Sinensis (Green Tea) Leaf Extract1, Aloe Barbadensis (Aloe Vera) Leaf Juice1, Caffeine, Hamamelis Virginiana (Witch Hazel) Extract, Lavandula Angustifolia (Lavender) Oil, Carrageenan (Seaweed Derived), Citric Acid, Potassium Hydroxide, Polysorbate 20, Xanthan Gum, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.

1 Certified Organic Ingredients

SPL UNCLASSIFIED SECTION

Distributed by DERMA E®
Simi Valley, CA 93065, USA

PRINCIPAL DISPLAY PANEL - 60 mL Jar Box

ANTI-ACNE

100% VEGAN SOY-FREE
ECO-ETHICAL
CRUELTY-FREE

DERMA E

Acne Blemish
Control
Treatment
Serum

Active Salicylic Acid
Tea Tree Oil
Aloe Vera

reduces acne,
blackheads and breakouts

DERMATOLOGIST
RECOMMENDED

2 FL OZ / 60 mL

INGREDIENTS AND APPEARANCE

DERMA E ACNE BLEMISH CONTROL TREATMENT SERUM 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-3851
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	190 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
HYDROXYPROPYL CORN AMYLOPECTIN, PHOSPHATE CROSSLINKED (4000 MPA.S AT 5%) (UNII: GSS77345H7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
NIACINAMIDE (UNII: 25X51I8RD4)
CARRAGEENAN (UNII: 5C69YCD2YJ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TEA TREE OIL (UNII: VIF565UC2G)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAFFEINE (UNII: 3G6A5W338E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
SALIX ALBA BARK (UNII: 205MXS71H7)
ROSEWOOD OIL (UNII: F2522O5L7B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-3851-1	1 in 1 BOX	02/22/2022
1		60 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	02/22/2022

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc		049121643	MANUFACTURE(54108-3851)