blackhead solutions 7 day deep pore cleanse and scrub acne medication

blackhead solutions 7 day deep pore cleanse and scrub acne medication

Drug Labeling and Warnings

Drug Details

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BLACKHEAD SOLUTIONS 7 DAY DEEP PORE CLEANSE AND SCRUB ACNE MEDICATION- salicylic acid cream 
CLINIQUE LABORATORIES 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.

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blackhead solutions 7 day deep pore cleanse and scrub acne medication

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 are 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

  • Apply to face daily, wet and massage, rinse off.

Inactive ingredients

water\aqua\eau kaolin glycerin butylene glycol magnesium aluminum silicate glyceryl stearate peg-100 stearate silica sodium lauroyl sarcosinate allyl methacrylates crosspolymer gentiana lutea (gentian) root extract laminaria saccharina extract sucrose acetyl glucosamine caprylyl glycol 1,2-hexanediol tocopheryl acetate sodium hydroxide xanthan gum disodium edta phenoxyethanol titanium dioxide (ci 77891) blue 1 (ci 42090) yellow 5 (ci 19140) [iln43442]

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

CLINIQUE

blackhead
solutions

7 day deep pore
cleanse & scrub

SALICYLIC ACID
ACNE MEDICATION

ALL SKIN TYPES

.5 FL.OZ.LIQ./15 ml e

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton
BLACKHEAD SOLUTIONS 7 DAY DEEP PORE CLEANSE AND SCRUB ACNE MEDICATION 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49527-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ) Salicylic acid0.0116 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
kaolin (UNII: 24H4NWX5CO)  
glycerin (UNII: PDC6A3C0OX)  
butylene glycol (UNII: 3XUS85K0RA)  
magnesium aluminum silicate (UNII: 6M3P64V0NC)  
glyceryl monostearate (UNII: 230OU9XXE4)  
peg-100 stearate (UNII: YD01N1999R)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sodium lauroyl sarcosinate (UNII: 632GS99618)  
sucrose (UNII: C151H8M554)  
n-acetylglucosamine (UNII: V956696549)  
caprylyl glycol (UNII: 00YIU5438U)  
1,2-hexanediol (UNII: TR046Y3K1G)  
sodium hydroxide (UNII: 55X04QC32I)  
xanthan gum (UNII: TTV12P4NEE)  
edetate disodium anhydrous (UNII: 8NLQ36F6MM)  
phenoxyethanol (UNII: HIE492ZZ3T)  
titanium dioxide (UNII: 15FIX9V2JP)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C yellow no. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49527-062-011 in 1 CARTON08/30/2018
120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D08/30/2018
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516RELABEL(49527-062) , REPACK(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.202952982MANUFACTURE(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157RELABEL(49527-062) , REPACK(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC LLC959338336MANUFACTURE(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774RELABEL(49527-062) , REPACK(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(49527-062)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(49527-062)

Revised: 9/2018
 
CLINIQUE LABORATORIES INC.


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