AVEDA OUTER PEACE ACNE RELIEF PADS- salicylic acid solution

AVEDA OUTER PEACE ACNE RELIEF PADS by

Drug Labeling and Warnings

AVEDA OUTER PEACE ACNE RELIEF PADS by is a Otc medication manufactured, distributed, or labeled by Aveda Corporation, Estee Lauder Companies Inc., Port Jervis Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Use

• treats acne
• clears acne blemishes
• helps prevent development of new acne blemishes

Warnings

For external use only

When using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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

Directions

• cleanse skin thoroughly before applying
• cover the entire affected area with one application daily
• gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to every other day
• if going outside, use a sunscreen. Allow product to dry, then follow sunscreen directions. If sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

Water/Aqua/Eau, Alcohol Denat., Betaine, PEG-60 Almond Glycerides, Calophyllum Inophyllum (Tamanu) Seed Oil, Boswellia Serrata Extract, Phyllanthus Emblica Fruit Extract, Serenoa Serrulata (Saw Palmetto) Fruit Extract, Caffeine, Sodium Salicylate, Fragrance (Parfum) 1 <ILN30711>

1 Aveda's Own Pure-Fume™ Aroma with Certified Organic Lemon Tea Tree and Rose Geranium Oils and Other Pure Flower and Plant Essences

PRINCIPAL DISPLAY PANEL - 50 Pad Jar Carton

AVEDA
THE ART AND SCIENCE OF PURE
FLOWER AND PLANT ESSENCES

outer peace ™

acne relief pads

salicylic acid treatment delivers medicine deep into pores

50 pads

INGREDIENTS AND APPEARANCE

AVEDA OUTER PEACE ACNE RELIEF PADS 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57677-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BETAINE (UNII: 3SCV180C9W)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
TAMANU OIL (UNII: JT3LVK84A1)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
SAW PALMETTO (UNII: J7WWH9M8QS)
CAFFEINE (UNII: 3G6A5W338E)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57677-064-01	1 in 1 CARTON	05/17/2021
1		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/17/2021

Labeler - Aveda Corporation (071352058)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Port Jervis Laboratories, Inc		001535103	manufacture(57677-064)