ANTI-AGING BLEMISH CONTROL SPOT TREATMENT- salicylic acid liquid

Anti-Aging Blemish Control Spot Treatment by

Drug Labeling and Warnings

Anti-Aging Blemish Control Spot Treatment by is a Otc medication manufactured, distributed, or labeled by June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient.

Salicylic Acid 1%.

PURPOSE

Purpose.

Acne Medication

INDICATIONS & USAGE

USE

For the treatment, Control and prevention of acne.

WARNINGS

Warnings

For external use only

■ Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor

■ Avoid contact with eyes. 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.

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

DOSAGE & ADMINISTRATION

Directions

■ Cleanse skin thoroughly before applying.

■ Cover the affected area with a thin layer one to three times a day.

■ Follow with moisturizer and sunscreen during the day.

■ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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

Inactive ingredients

Water/Aqua/Eau, Alcohol Denat., Propanediol, Glycerin, Salix Nigra (Willow) Bark Extract, Fragrance/Parfum, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Helianthus Annuus (Sunflower) Seed Oil, Lactic Acid, Ascophyllum Nodosum Extract, Brassica Oleracea Italica (Broccoli) Extract, Curcuma Longa (Turmeric) Root Extract, Chlorella Vulgaris Extract, Menthol, Camphor, Globularia Alypum Leaf Extract, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Malic Acid, Alginic Acid, Arnica Montana Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Disodium Phosphate, Polysorbate 60, Tocopherol, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis Leaf Extract, Sodium Phosphate, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool, Benzyl Benzoate, Eugenol, Citral, Geraniol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-AGING BLEMISH CONTROL SPOT TREATMENT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.1479 g  in 14.79 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM PHOSPHATE (UNII: SE337SVY37)
EUGENOL (UNII: 3T8H1794QW)
BENZYL BENZOATE (UNII: N863NB338G)
CARYOPHYLLENE (UNII: BHW853AU9H)
MALIC ACID (UNII: 817L1N4CKP)
PROPANEDIOL (UNII: 5965N8W85T)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MENTHOL (UNII: L7T10EIP3A)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BROCCOLI SPROUT (UNII: 128UH9LOAE)
ALGINIC ACID (UNII: 8C3Z4148WZ)
3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)
GLYCERIN (UNII: PDC6A3C0OX)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
MANDARIN OIL (UNII: NJO720F72R)
CLOVE LEAF OIL (UNII: VCA5491KVF)
CITRAL (UNII: T7EU0O9VPP)
TURMERIC (UNII: 856YO1Z64F)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLOBULARIA CORDIFOLIA WHOLE (UNII: SD327VQ78H)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LINALYL ACETATE (UNII: 5K47SSQ51G)
CITRONELLA OIL (UNII: QYO8Q067D0)
GERANIOL (UNII: L837108USY)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GINGER OIL (UNII: SAS9Z1SVUK)
LACTIC ACID (UNII: 33X04XA5AT)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
CHAMOMILE (UNII: FGL3685T2X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-109-05	14.79 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/13/2012
2	NDC: 65278-109-02	14.79 g in 1 CARTON; Type 0: Not a Combination Product	02/13/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/13/2012

Labeler - June Jacobs Labs, LLC (082439410)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		122610681	manufacture(65278-109)