La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser: Package Insert and Label Information

LA ROCHE POSAY LABORATORIE DERMATOLOGIQUE EFFACLAR MEDICATED CLEANSER- salicylic acid gel
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 2%

Purpose

Acne treatment

Use

for the treatment of acne

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

  • use twice daily
  • wet face, then work product into a lather
  • massage onto face, avoiding the eyes
  • rinse well

Inactive ingredients

water, sodium laureth sulfate, decyl glucoside, glycerin, sodium chloride, coco-betaine, PEG-150 pentaerythrityl tetrastearate, hexylene glycol, sodium hydroxide, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, citric acid

Questions or comments?

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LA ROCHE POSAY LABORATORIE DERMATOLOGIQUE EFFACLAR MEDICATED CLEANSER
salicylic acid gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-023
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM LAURETH SULFATE
DECYL GLUCOSIDE
GLYCERIN
SODIUM CHLORIDE
COCO-BETAINE
PEG-150 PENTAERYTHRITYL TETRASTEARATE
HEXYLENE GLYCOL
SODIUM HYDROXIDE
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES
ZINC GLUCONATE
MENTHOL
CAPRYLOYL SALICYLIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-023-01 200 mL in 1 TUBE None
2 NDC:49967-023-02 100 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/01/2014
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L’Oreal USA, Inc. 185931458 manufacture (49967-023)

Revised: 01/2020 L’Oreal USA Products Inc

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