SIMPLY VITAL ACNE FACE CREAM- salicylic acid cream

SIMPLY VITAL Acne Face Cream by

Drug Labeling and Warnings

SIMPLY VITAL Acne Face Cream by is a Otc medication manufactured, distributed, or labeled by ALPHA PLANTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Salicylic acid 2.0%

Purpose

Acne Treatment

Uses:

• for the treatment of acne

Warnings:

For external use only.

When using this product

skin irritation and dryness is more likely to occr 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.

If pregnant or breast-feeding,

ask a health professional before use.

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 appilcation daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• if bothersome dryness or peeling occur, reduce application to once a day or every other day.

Other information:

• protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Deionized Water, Butylene Glycol, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Dimethicone, Dodecane, Echinacea Purpurea (Coneflower) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Polysorbate-20, Pyrus Malus (Apple Cider Vinegar), Sodium Hydroxide, Sodium PCA, Cymbopogon Schoenanthus (Lemongrass) Oil, Tocopheryl Acetate (Vitamin E), Xanthan Gum.

Questions?

+1 (205) 624-9177  

Package Labeling:

INGREDIENTS AND APPEARANCE

SIMPLY VITAL ACNE FACE CREAM 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82460-272
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
DODECANE (UNII: 11A386X1QH)
ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TEA TREE OIL (UNII: VIF565UC2G)
PEPPERMINT OIL (UNII: AV092KU4JH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
APPLE CIDER VINEGAR (UNII: 0UE22Q87VC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82460-272-00	60 mL in 1 JAR; Type 0: Not a Combination Product	02/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/01/2022

Labeler - ALPHA PLANTS INC (118246522)