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

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL TARGETED ACNE SPOT TREATMENT- sulfur 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


Sulfur 10%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use on

  • broken skin
  • large areas of the skin

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.
  • apply only to areas with acne

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 ingredient

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, magnesium aluminum silicate, phenoxyethanol, polyacrylamide, ceteareth-20, sodium hydroxide, PEG-100 stearate, phenylethyl resorcinol, tocopheryl acetate, C13-14 isoparaffin, disodium EDTA, laureth-7, allantoin, aloe barbadensis leaf juice, hydrogenated lecithin, ethylhexylglycerin, glycyrrhiza glabra (licorice) root extract

Questions or comments?

Call toll free 1-800-946-4453

image of a label
(click image for full-size original)
image of a label
(click image for full-size original)

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL TARGETED ACNE SPOT TREATMENT
sulfur lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-895
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR (SULFUR) SULFUR 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
NIACINAMIDE
GLYCOLIC ACID
STEARYL ALCOHOL
GLYCERIN
PHENOXYETHANOL
SODIUM HYDROXIDE
PEG-100 STEARATE
PHENYLETHYL RESORCINOL
ALLANTOIN
ETHYLHEXYLGLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-895-01 1 TUBE in 1 CARTON contains a TUBE
1 20 mL in 1 TUBE This package is contained within the CARTON (49967-895-01)
2 NDC:49967-895-02 3 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 (49967-895)

Revised: 01/2020 L’Oreal USA Products Inc

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.