ACNE CARE LOTN- salicylic acid lotion

Acne Care Lotn by

Drug Labeling and Warnings

Acne Care Lotn by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Salicylic Acid (0.5%)..........Acne Treatment

Sulfur (2.0%)......................Acne Treatment

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

For treatment of acne

WARNINGS

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

WHEN USING

When using this product

Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

Other Ingredients:

Aqua, PEG – 100 Stearate, Glyceryl Stearate, Glycerin, Stearic Acid, Cetyl Alcohol, Titanium Dioxide, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Zinc Oxide, Hydroxyethyl Cellulose, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Chloroxylenol, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Malus Domestica (Apple) Fruit Cell Culture Extract, Citric Acid, Lactic Acid, Malic Acid, Gluconic Acid, Glycolic Acid, Salicylic Acid, Tartaric Acid, *CO Alcohol, *CO Glycerin, *CO Salix Alba Bark Extract, *CO Avena Sativa (Oat) Kernel Extract, *CO Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, *CO Pogostemon Cablin Oil, *CO Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Sea Salt, **Squalane, Fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE CARE LOTN 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-2267
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 mg  in 100 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID D7 (UNII: T3B081197X)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-2267-1	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/19/2023

Labeler - Spa de Soleil (874682867)

Registrant - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-2267)