Label: BREAST ESSENCE II- dimethicone, allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69142-001-01, 69142-001-02 - Packager: yeojaya
- 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 July 29, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- INSTRUCTIONS FOR USE
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INACTIVE INGREDIENT
Pure water, Butylene glycol, Anemarrhena asphodeloides bunge extract, Propylene glycol, Cetyl alcohol, Glyceryl stearate/PEG-100-Stearate, Betaine, Arbutin, Phytrogen, Sorbitan sesquioleate, Polysorbate 80, Sorbitan stearate, Macadamia ternifolia seed oil, Simmondsia chinensis seed oil, Dipotassium glycyrrhizate, Triethanolamine, 1,2-hexandediol, Adenosine, Carbomer, Tocopheryl acetate, Sodium hyaluronate, Cultured wild ginseng roots extracts, Rose extract, Soybean extract, Portulaca oleracea extract, Perfume
- PRINCIPAL DISPLAY PANEL
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
BREAST ESSENCE II
dimethicone, allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69142-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.5 mg in 50 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 1 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ANEMARRHENA ASPHODELOIDES WHOLE (UNII: OH50MKZ7H3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL STEARATE (UNII: 06RI5UQA7L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BETAINE (UNII: 3SCV180C9W) ARBUTIN (UNII: C5INA23HXF) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) MACADAMIA OIL (UNII: 515610SU8C) JOJOBA OIL (UNII: 724GKU717M) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) TROLAMINE (UNII: 9O3K93S3TK) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Adenosine (UNII: K72T3FS567) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ASIAN GINSENG (UNII: CUQ3A77YXI) SOYBEAN SEED OIL (UNII: P6C7NVO1UF) PURSLANE (UNII: M6S840WXG5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69142-001-02 1 in 1 CARTON 07/29/2014 1 NDC:69142-001-01 50 mL in 1 BOTTLE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/29/2014 Labeler - yeojaya (688735127) Registrant - yeojaya (688735127) Establishment Name Address ID/FEI Business Operations yeojaya 688735127 manufacture(69142-001)