Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment Facial: Package Insert and Label Information

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL ACNE TREATMENT FACIAL- salicylic acid lotion
L’Oreal USA Products Inc

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.

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Uses

  • for the treatment of acne
  • helps prevent new acne blemishes

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 a time.

Keep out of reach of children.

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

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 ingredients

water, aloe barbadensis leaf juice, di-C12-13 alkyl malate, niacinamide, cyclohexasiloxane, propylene glycol, aluminum starch octenylsuccinate, PEG-100 stearate, glyceryl stearate, cetyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, capryloyl salicylic acid, xanthan gum, zinc PCA, zingiber officinale (ginger) root extract, stearyl alcohol, myristyl alcohol, citric acid, potassium sorbate, octadecenedioic acid, sodium benzoate, citral, BHT

Questions or comments?

Call toll free 1-800-946-4453

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KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL ACNE TREATMENT FACIAL
salicylic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-875
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
NIACINAMIDE
PROPYLENE GLYCOL
ALUMINUM STARCH OCTENYLSUCCINATE
PEG-100 STEARATE
CETYL ALCOHOL
SODIUM HYDROXIDE
CAPRYLOYL SALICYLIC ACID
XANTHAN GUM
STEARYL ALCOHOL
MYRISTYL ALCOHOL
OCTADECENEDIOIC ACID
CITRAL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-875-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 mL in 1 BOTTLE This package is contained within the CARTON (49967-875-01)
2 NDC:49967-875-02 5 mL in 1 PACKET None
3 NDC:49967-875-03 1.5 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/01/2016
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-875)

Revised: 01/2020 L’Oreal USA Products Inc

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