SPL v3
SPL
SPL Set ID cab1d71c-e017-4ff3-853b-b0e47dc1ee79
Route
TOPICAL
Published
Effective Date 2012-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Pidolate (.072 mg) Salicylic Acid (12 mg) Iris Germanica Var. Florentina Root (1.8 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Decyl Glucoside Zinc Acetylmethionate Sunflower Seed Hedera Helix Leaf Glycerin Polyethylene Glycol 400 Caprylyl Glycol Sodium Polyacrylate (8000 Mw) Sodium Chloride Alcohol Propylene Glycol Butylene Glycol Fytic Acid Biotin Trolamine Linalool, (+/-)- Isomethyl-.alpha.-ionone Hydroxyisohexyl 3-cyclohexene Carboxaldehyde Butylated Hydroxytoluene Methylisothiazolinone Chlorhexidine Gluconate Phenoxyethanol Methylparaben Butylparaben Ethylparaben Propylparaben Isobutylparaben Vitamin A Palmitate Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-07-18

Description

Key Active Ingredients Zinc PCA, Salicylic Acid, Iris Flower Extract


Medication Information

Warnings and Precautions
Warnings

Indications and Usage
Lange Gel will turn into foam, during application. It will cleanse skin thoroughly without any dryness effect, in order to avoid hyperseboohea phenomenon, a main cause of acne.
Dosage and Administration
120 mL / 4.05 FL OZ.

Description

Key Active Ingredients Zinc PCA, Salicylic Acid, Iris Flower Extract

Section 50565-1
Keep out of reach of children.
Section 51727-6
Ingredients:AQUA,SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-40 HYDROGENATED CASTOR OIL DECYL GLUCOSIDE, ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER, IRIS FLORENTINA ROOT EXTRACT, ZINC PCA, ZINC ACETYLMETHIONATE, HELIANTHUS ANNUUS SEED EXTRACT, HEDERA HELIX LEAF/STEM EXTRACT,SALICYLIC ACID, GLYCERIN,PEG-8, CAPRYLYL GLYCOL,PPG-1-PEG-9 LAURYL GLYCOL ETHER,SODIUM POLYACRYLATE,SODIUM CHLORIDE,ALCOHOL,PROPYLENE GLYCOL,BUTYLENE GLYCOL,PHYTIC ACID,BIOTIN,TRIETHANOLAMINE,PARFUM,LINALOOL,ALPHA-ISOMETHYL IONONE, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE,RETINYL PALMITATE,BHT,METHYLISOTHIAZOLINONE,CHLORHEXIDINE DIGLUCONATE,PHENOXYETHANOL,METHYLPARABEN,BUTYLPARABEN, ETHYLPARABEN,PROPYLPARABEN,ISOBUTYLPARABEN,CI 42090 (BLUE 1)
Section 51945-4

Section 55105-1
The Answer to Acne Prone Skin

Cleansing Foaming Gel Lange

  • Purifying with an astingent activity,
  • Anti-inflammatory,
  • Antiseptic
Section 55106-9
Key Active Ingredients

Zinc PCA, Salicylic Acid, Iris Flower Extract

Structured Label Content

Indications and Usage (34067-9)
Lange Gel will turn into foam, during application. It will cleanse skin thoroughly without any dryness effect, in order to avoid hyperseboohea phenomenon, a main cause of acne.
Dosage and Administration (34068-7)
120 mL / 4.05 FL OZ.

Warnings and Precautions (34071-1)
Warnings

Section 50565-1 (50565-1)
Keep out of reach of children.
Section 51727-6 (51727-6)
Ingredients:AQUA,SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, PEG-40 HYDROGENATED CASTOR OIL DECYL GLUCOSIDE, ACRYLATES/STEARETH-20 METHACRYLATE COPOLYMER, IRIS FLORENTINA ROOT EXTRACT, ZINC PCA, ZINC ACETYLMETHIONATE, HELIANTHUS ANNUUS SEED EXTRACT, HEDERA HELIX LEAF/STEM EXTRACT,SALICYLIC ACID, GLYCERIN,PEG-8, CAPRYLYL GLYCOL,PPG-1-PEG-9 LAURYL GLYCOL ETHER,SODIUM POLYACRYLATE,SODIUM CHLORIDE,ALCOHOL,PROPYLENE GLYCOL,BUTYLENE GLYCOL,PHYTIC ACID,BIOTIN,TRIETHANOLAMINE,PARFUM,LINALOOL,ALPHA-ISOMETHYL IONONE, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE,RETINYL PALMITATE,BHT,METHYLISOTHIAZOLINONE,CHLORHEXIDINE DIGLUCONATE,PHENOXYETHANOL,METHYLPARABEN,BUTYLPARABEN, ETHYLPARABEN,PROPYLPARABEN,ISOBUTYLPARABEN,CI 42090 (BLUE 1)
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
The Answer to Acne Prone Skin

Cleansing Foaming Gel Lange

  • Purifying with an astingent activity,
  • Anti-inflammatory,
  • Antiseptic
Section 55106-9 (55106-9)
Key Active Ingredients

Zinc PCA, Salicylic Acid, Iris Flower Extract

Advanced Ingredient Data


Raw Label Data

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