Label: CLINIQUE CLARIFYING MAKEUP- salicylic acid powder
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-006-01, 49527-006-02 - Packager: CLINIQUE LABORATORIES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 20, 2011
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
talc [] dimethicone [] silica [] zea mays (corn) starch [] polymethyl methacrylate [] zinc stearate [] cetearyl ethylhexanoate [] trimethylsiloxysilicate [] sucrose [] ethylhexylglycerin [] nylon-12 [] octyldodecyl lactate [] lauroyl lysine [] pca [] lauryl alcohol [] bht [] chlorphenesin [] potassium sorbate [] tetrasodium edta [] [+/- mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891) [] yellow 5 lake (ci 19140) [] chromium oxide greens (ci 77288) [] chromium hydroxide green (ci 77289) [] carmine (ci 75470) [] bismuth oxychloride (ci 77163) [] blue 1 lake (ci 42090) [] yellow 6 lake (ci 15985) [] red 7 lake (ci 15850) [] red 6 (ci 15850) [] red 30 (ci 73360) [] ferric ferrocyanide (ci 77510
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLINIQUE CLARIFYING MAKEUP
salicylic acid powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-006 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 g Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) DIMETHICONE (UNII: 92RU3N3Y1O) STARCH, CORN (UNII: O8232NY3SJ) ZINC STEARATE (UNII: H92E6QA4FV) SUCROSE (UNII: C151H8M554) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-006-01 1 in 1 CARTON 1 NDC:49527-006-02 11 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/01/2010 Labeler - CLINIQUE LABORATORIES INC (173047747) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture Establishment Name Address ID/FEI Business Operations INTERCOS 338578473 manufacture