OTC Medication Information: Tiege Hanley Daily Moisturizing Acne

TIEGE HANLEY DAILY MOISTURIZING ACNE- salicylic acid cream
TIEGE HANLEY,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.

Drug Facts

Active Ingredients

Salicylic Acid 1.6%

Purpose

Acne Treatment

Uses

  • For the management of acne

Warnings

  • For External Use Only

When using this product

  • do not use this product more than twice per day
  • discontinue use if skin irritation occurs
  • avoid contact with eyes
  • if going outside, apply sunscreen after using this product
  • skin irritation and dryness are more likely to occur if you use more than one acne medication at the same time
  • if irritations occur only use one topical acne medication at a time
  • avoid aggressive soaps if irritations are experienced

Do not use if you

  • have very sensitive skin
  • are sensitive to salicylic acid

Stop use and ask a doctor if irritation becomes severe

Keep out of reach of children

  • if swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Clean face thoroughly with Tiege Hanley WASH before applying this product
  • Dispense approximately 3 pumps–enough to cover the entire affected area with a thin layer, including the face and neck
  • For best results, use before bedtime
  • For severe acne, add morning application after WASH, only if followed by AM moisturizer with SPF 20
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once per day or every other day

Inactive Ingredients

Aqua, Glycerin, Cyclopentasiloxane, Cocamidopropyl Dimethylamine, Ethyl Palmate, Behenyl Alcohol, Zea Mays (Corn) Starch, Beheneth-5, Polyglyceryl-3 Stearate, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ceteareth-25, Medicago Sativa (Alfalfa) Extract, Plantago Major Leaf Extract, Calendula Officinalis Flower Extract, Aleurites Moluccanus Seed Oil, Xanthan Gum, Sodium Hyaluronate

Other Information

  • When not using, keep at room temperature with the cap closed
  • Distributed by Tiege Hanley, Inc.
    Chicago, IL 60612

PRINCIPAL DISPLAY PANEL — 24 g Bottle Label

TIÉGE
HANLEY

Uncomplicated
Skin Care for Men®

ACNE

Daily Moisturizing
Acne Cream

Net Wt 0.85 oz (24 g)

Principal Display Panel -- 24 g Bottle Label
(click image for full-size original)
TIEGE HANLEY DAILY MOISTURIZING ACNE
salicylic acid cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71714-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 16 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
STARCH, CORN
XANTHAN GUM
GLYCERIN
POLYGLYCERYL-3 STEARATE
BEHENETH-5
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
CETEARETH-25
ETHYL PALMATE
DOCOSANOL
CYCLOMETHICONE 5
ALFALFA TOP
PLANTAGO MAJOR LEAF
CALENDULA OFFICINALIS FLOWER
HYALURONATE SODIUM
PHENOXYETHANOL
CAPRYLYL GLYCOL
KUKUI NUT OIL
COCAMIDOPROPYL DIMETHYLAMINE
Product Characteristics
Color WHITE (off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71714-002-24 24 g in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2018
Labeler — TIEGE HANLEY,Inc. (080305325)
Establishment
Name Address ID/FEI Operations
BMC 1092, Inc. dba Solo Laboratories, Inc 078831987 MANUFACTURE (71714-002), PACK (71714-002)

Revised: 03/2023 TIEGE HANLEY,Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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