NEORA COMPLEXION CLEARING- salicylic acid swab

Neora by

Drug Labeling and Warnings

Neora by is a Otc medication manufactured, distributed, or labeled by Neora, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Salicylic acid 0.5%

PURPOSE

Purpose

Acne treatment

INDICATIONS & USAGE

Use

for the treatment of acne

WARNINGS

Warnings

For external use only.

WHEN USING

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• cleanse the skin thoroughly before applying this product.
• apply pre-soaked pad to entire face or 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

Inactive ingredients Aloe barbadensis leaf juice, bilberry (Vaccinium myrtillus) fruit extract, caprylyl glycol, citric acid, disodium EDTA, disodium tetramethylhexadecenylcysteine formylprolinate, lauryl glucoside, lemon (Citrus limon) fruit extract, niacinamide, orange (Citrus aurantium dulcis) fruit extract, phenoxyethanol, PPG-5 ceteth-20, sodium hydroxide, sodium lauryl glucose carboxylate, sugar cane (Saccharum officinarum) extract, sugar maple (Acer saccharum) extract, water, witch hazel (Hamamelis virginiana) bark/leaf/twig extract.

SPL UNCLASSIFIED SECTION

Free from: Parabens Synthetic Colorants Synthetic Fragrance Propylene Glycol

Distributed by:

Neora, LLC, Dallas, TX 75244

1.855.463.7486

www.neora.com

PRINCIPAL DISPLAY PANEL

NEORA™

COMPLEXION CLEARING

SALICYLIC ACID ACNE TREATMENT PADS

45 PADS

INGREDIENTS AND APPEARANCE

NEORA  COMPLEXION CLEARING
salicylic acid swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72935-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BILBERRY (UNII: 9P2U39H18W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
NIACINAMIDE (UNII: 25X51I8RD4)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)
SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB)
ACER SACCHARUM SAP (UNII: 75UOH57984)
WATER (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72935-001-45	1 in 1 CARTON	05/01/2019
1		45 in 1 JAR
1		1.1 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2019

Labeler - Neora, LLC (055050917)