blemish care gel cream with bija seed oil

Drug Labeling and Warnings

Drug Details [pdf]

BLEMISH CARE WITH BIJA SEED OIL- salicylic acid lotion 
Innisfree

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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blemish care gel cream with bija seed oil

Drug Facts

Active ingredient

Salicylic Acid (2%)

Purpose

Acne treatment

Uses

• For the treatment of acne.
• Helps clear up acne blemishes and allows skin to heal
• Penetrates pores to control acne pimples
• Helps prevent new acne blemishes, pimples from forming

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 the same time.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• cleanse 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.

Other information

Store at room temperature.

Inactive ingredients

water, propanediol, alcohol, cyclopentasiloxane, cyclohexasiloxane, peg-8, polyacrylate crosspolymer-6, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, potassium hydroxide, ammonium acryloyldimethyltaurate/vp copolymer, polysorbate 20, dimethiconol, dimethicone, fragrance, dimethicone/vinyl dimethicone crosspolymer, glyceryl caprylate, glycerin, t-butyl alcohol, disodium edta, torreya nucifera seed oil, camellia japonica leaf extract, camellia sinensis leaf extract, citrus unshiu peel extract, opuntia coccinellifera fruit extract, orchid extract

PRINCIPAL DISPLAY PANEL - 40 ml Container Carton

innisfree

blemish care
gel cream
with bija seed oil

1.35 FL.OZ./40ml

BLEMISH CARE WITH BIJA SEED OIL 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71220-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERIN (UNII: PDC6A3C0OX)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TORREYA NUCIFERA SEED OIL (UNII: 33JR96IW2B)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-001-08	1 in 1 CARTON	03/03/2017	10/14/2019
1		40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/03/2017	10/14/2019

Labeler - Innisfree (557822425)

Establishment
Name	Address	ID/FEI	Business Operations
COSVISION		557789645	manufacture(71220-001)

Revised: 10/2019

Document Id: 94f58b2b-9543-2aea-e053-2995a90aa6ea

34390-5

Set id: 8376d2d5-de4e-4fcc-9f5c-7f346a413ab3

Version: 2

Effective Time: 20191015