blemish care emulsion with bija seed oil

Drug Labeling and Warnings

Drug Details [pdf]

BLEMISH CARE WITH BIJA SEED- salicylic acid lotion 
Innisfree Corporation

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 emulsion with bija seed oil

Drug Facts

Active ingredient

Salicylic Acid (0.6%)

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, squalane, cyclopentasiloxane, cyclohexasiloxane, glyceryl stearate, niacinamide, cetyl alcohol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, octyldodecanol, silica, torreya nucifera seed oil, cetearyl alcohol, peg-100 stearate, tromethamine, peg-75 stearate, fragrance, xanthan gum, polyacrylate-13, ceteth-20, steareth-20, glyceryl caprylate, polyisobutene, ethylhexylglycerin, camellia japonica leaf extract, camellia sinensis leaf extract, citrus unshiu peel extract, opuntia coccinellifera fruit extract, orchid extract, disodium edta, polysorbate 20, sorbitan isostearate

PRINCIPAL DISPLAY PANEL - 100 ml Container Carton

innisfree

blemish care
emulsion
with bija seed oil

3.38 FL.OZ./100ml

BLEMISH CARE WITH BIJA SEED 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71220-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
ALCOHOL (UNII: 3K9958V90M)
SQUALANE (UNII: GW89575KF9)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TORREYA NUCIFERA SEED OIL (UNII: 33JR96IW2B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
TROMETHAMINE (UNII: 023C2WHX2V)
PEG-75 STEARATE (UNII: OT38R0N74H)
XANTHAN GUM (UNII: TTV12P4NEE)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TANGERINE PEEL (UNII: JU3D414057)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71220-005-04	1 in 1 CARTON	05/13/2017	10/14/2019
1		100 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	05/13/2017	10/14/2019

Labeler - Innisfree Corporation (557822425)

Establishment
Name	Address	ID/FEI	Business Operations
COSVISION		557789645	manufacture(71220-005)

Revised: 10/2019

Document Id: 94f5cbdd-307b-9e17-e053-2a95a90a2e96

34390-5

Set id: 65326e5c-aac4-44e2-96f4-a2a1bd664d0c

Version: 2

Effective Time: 20191015