BLACKHEAD SOLUTIONS SELF-HEATING BLACKHEAD EXTRACTOR ACNE MEDICATION- salicylic acid cream

blackhead solutions self-heating blackhead extractor acne medication by

Drug Labeling and Warnings

blackhead solutions self-heating blackhead extractor acne medication by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1.0%

Purpose

Acne Treatment

Uses

• reduces the number of blackheads
• helps keep skin clear of new blackheads
• helps prevent development of new blackheads

Warnings

For external use only

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 one topical acne 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. Keep out of eyes.

Directions

• Use 3 times a week on clean, dry skin.
• Unscrew top to dispense product.
• Apply thin layer on blackhead-prone areas.
• Reattach top.
• Wet product on skin to activate heat.
• Massage 15-30 seconds with applicator tip, then rinse.

Inactive ingredients

magnesium sulfate dimethicone isononyl isononanoate isododecane polysilicone-11 phenyl trimethicone hydrogenated lecithin acetyl glucosamine polysorbate 20 polysorbate 80 polyethylene diatomaceous earth\solum diatomeae\terre de diatomées triethylhexanoin pumice bambusa arundinacea (bamboo) stem extract peg-15/lauryl dimethicone crosspolymer caprylyl glycol stearyl glycyrrhetinate water\aqua\eau silica [iln43644]

PRINCIPAL DISPLAY PANEL - 20 ml Bottle Carton

blackheads

CLINIQUE

blackhead
solutions

self-heating
blackhead
extractor

SALICYLIC ACID
ACNE MEDICATION

ALL SKIN TYPES

.68 FL.OZ.LIQ./20 ml e

INGREDIENTS AND APPEARANCE

BLACKHEAD SOLUTIONS SELF-HEATING BLACKHEAD EXTRACTOR ACNE MEDICATION 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ)	Salicylic acid	0.0116 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
magnesium sulfate, unspecified form (UNII: DE08037SAB)
dimethicone (UNII: 92RU3N3Y1O)
isononyl isononanoate (UNII: S4V5BS6GCX)
isododecane (UNII: A8289P68Y2)
phenyl trimethicone (UNII: DR0K5NOJ4R)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
n-acetylglucosamine (UNII: V956696549)
polysorbate 20 (UNII: 7T1F30V5YH)
polysorbate 80 (UNII: 6OZP39ZG8H)
high density polyethylene (UNII: UG00KM4WR7)
diatomaceous earth (UNII: 2RF6EJ0M85)
triethylhexanoin (UNII: 7K3W1BIU6K)
pumice (UNII: NT5NN5KL16)
caprylyl glycol (UNII: 00YIU5438U)
stearyl glycyrrhetinate (UNII: 3YYE6VJS0P)
water (UNII: 059QF0KO0R)
silicon dioxide (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-061-01	1 in 1 CARTON	08/30/2018
1		20 mL in 1 BOTTLE, WITH 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	08/30/2018

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-061) , REPACK(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-061) , REPACK(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-061) , REPACK(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-061)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-061)