MDACNE CUSTOMIZED ACNE CLEANSER HYDRATING SALICYLIC ACID- salicylic acid cream

MDacne Customized Acne Cleanser Hydrating Salicylic Acid by

Drug Labeling and Warnings

MDacne Customized Acne Cleanser Hydrating Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by MDAlgorithms Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Salicylic Acid 0.50%

Purpose

Acne Treatment

Use:

For the treatment of Acne. Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

For external use only.

• Use of this product may increase dryness or irritation of the skin.
• Because excessive drying of the skin may occur, start with one use daily. Gradually increase to two times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once per day.

  Do not use 

for prolonged periods without consulting a doctor.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Directions:

Wet face. Gently massage product over entire face for 20-30 seconds. Rinse thoroughly and pat dry. Recommended for daily use.

Other information:

Store in a cool, dry place below 20ºC (70ºF).

Inactive Ingredients:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Cocamide MEA Cocamidopropyl Betaine, Disodium Oleamide MEA Sulfosuccinate, Ethylhexylglycerin, Glycerin, Glycol Stearate, Glycolic Acid (AHA), Glycyrrhiza Glabra (Licorice) Root Extract, Hamamelis Virginiana (Witch hazel), Hydroxypropyltrimonium Guar, Parfum (fragrance), PEG-25 Hydrogenated Castor Oil, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E).

Questions:

Contact us at support@mdacne.com

Package Labelling:

INGREDIENTS AND APPEARANCE

MDACNE CUSTOMIZED ACNE CLEANSER HYDRATING SALICYLIC ACID 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71804-534
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL STEARATE (UNII: 0324G66D0E)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WITCH HAZEL (UNII: 101I4J0U34)
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71804-534-00	59 mL in 1 TUBE; Type 0: Not a Combination Product	09/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/12/2024

Labeler - MDAlgorithms Inc (080479826)