Label: SERATIN- vernel kozmetik soap
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Contains inactivated NDC Code(s)
NDC Code(s): 79652-011-01, 79652-011-02, 79652-011-03 - Packager: VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- WHEN USING
- PURPOSE
- WARNINGS
- ACTIVE INGREDIENT
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
glycerin, sodium laureth sulfate, lauramine oxide, cocamidopropyl betaine, edetate sodium, water, citric acid monohydrate, polyquaternium-7,aloe vera leaf,cocamide, cetrimonium chloride,methylchloroisothiazolinone,styrene/ acrylamide copolymer, fragrance lavender& chia F-153480, alpha-tocopherol acetate, sodium chloride
- DOSAGE FORM : SOAP
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SERATIN
vernel kozmetik soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79652-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength EDETATE SODIUM (UNII: MP1J8420LU) 0.05 mL in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.1 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL in 100 mL FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.5 mL in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 2 mL in 100 mL STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) 0.6 mL in 100 mL COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 3 mL in 100 mL WATER (UNII: 059QF0KO0R) 74.9 mL in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 mL in 100 mL METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) 0.1 mL in 100 mL CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.5 mL in 100 mL SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 12 mL in 100 mL COCAMIDE (UNII: 3YXD33R71G) 2 mL in 100 mL LAURAMINE OXIDE (UNII: 4F6FC4MI8W) 3 mL in 100 mL POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) 0.1 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79652-011-01 450 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2020 2 NDC:79652-011-02 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2020 3 NDC:79652-011-03 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/02/2020 Labeler - VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (519821634) Registrant - VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (519821634) Establishment Name Address ID/FEI Business Operations VERNEL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI 519821634 manufacture(79652-011)
