Label: BABY ESSENTIALS GIFT SET- benzalkonium chloride kit
- NDC Code(s): 59062-4000-5, 59062-5000-1
- Packager: KAS Direct LLC dba BabyGanics
- 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 November 4, 2020
If you are a consumer or patient please visit this version.
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - Kit Package
babyganics
baby
essentials
gift set1- daily lotion chamomile verbena (9 FL OZ)
1- bubble bath chamomile verbena (9 FL OZ)
1- foaming shampoo+body wash chamomile verbena (7 FL OZ)
1- foaming dish & bottle soap fragrance free (3 FL OZ)
1- toy, table & highchair wipes fragrance free (25 wipes)
2- alcohol-free foaming hand sanitizer mandarin (50 ML)Discover which ingredients are Certified Organic on bottom panel.
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INGREDIENTS AND APPEARANCE
BABY ESSENTIALS GIFT SET
benzalkonium chloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-5000 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-5000-1 1 in 1 PACKAGE; Type 0: Not a Combination Product 01/01/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 266 mL Part 2 1 BOTTLE 266 mL Part 3 1 BOTTLE 207 mL Part 4 2 BOTTLE, PUMP 100 mL Part 5 1 PACKAGE 25 Part 6 1 BOTTLE, DISPENSING 89 mL Part 1 of 6 MOISTURIZING DAILY
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR water (UNII: 059QF0KO0R) INGR COCOA BUTTER (UNII: 512OYT1CRR) INGR cetyl alcohol (UNII: 936JST6JCN) INGR squalene (UNII: 7QWM220FJH) INGR decyl oleate (UNII: ZGR06DO97T) INGR shea butter (UNII: K49155WL9Y) INGR propanediol (UNII: 5965N8W85T) INGR glycerin (UNII: PDC6A3C0OX) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR OLIVE OIL (UNII: 6UYK2W1W1E) INGR canola oil (UNII: 331KBJ17RK) INGR tocopherol (UNII: R0ZB2556P8) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR TOMATO SEED OIL (UNII: 7N87T9C06T) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR CRANBERRY SEED OIL (UNII: 73KDS3BW5E) INGR NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT) INGR RASPBERRY SEED OIL (UNII: 9S8867952A) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR stearic acid (UNII: 4ELV7Z65AP) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) INGR sodium hydroxide (UNII: 55X04QC32I) INGR caprylyl glycol (UNII: 00YIU5438U) INGR TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) INGR sorbic acid (UNII: X045WJ989B) INGR phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 266 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2015 Part 2 of 6 BUBBLE BATH
bubble bath liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR water (UNII: 059QF0KO0R) INGR sodium lauroyl methyl isethionate (UNII: II6VCD3S6R) INGR disodium cocoamphodiacetate (UNII: 18L9G3U51M) INGR coco glucoside (UNII: ICS790225B) INGR lauryl glucoside (UNII: 76LN7P7UCU) INGR capryl/capramidopropyl betaine (UNII: 231H3ZT9NE) INGR TOMATO SEED OIL (UNII: 7N87T9C06T) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR CRANBERRY SEED OIL (UNII: 73KDS3BW5E) INGR NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT) INGR RASPBERRY SEED OIL (UNII: 9S8867952A) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) INGR CHAMOMILE (UNII: FGL3685T2X) INGR OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) INGR glycerin (UNII: PDC6A3C0OX) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ethylhexylglycerin (UNII: 147D247K3P) INGR sodium benzoate (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 266 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2015 Part 3 of 6 SQUEEZE AND FOAM SHAMPOO PLUS BODY WASH
baby shampoos shampooProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR water (UNII: 059QF0KO0R) INGR sodium lauroyl methyl isethionate (UNII: II6VCD3S6R) INGR CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) INGR propanediol (UNII: 5965N8W85T) INGR BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) INGR sodium lauroyl oat amino acids (UNII: FSW2K9B9N5) INGR glycerin (UNII: PDC6A3C0OX) INGR ethylhexylglycerin (UNII: 147D247K3P) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR trisodium ethylenediamine disuccinate (UNII: YA22H34H9Q) INGR dehydroacetic acid (UNII: 2KAG279R6R) INGR TOMATO SEED OIL (UNII: 7N87T9C06T) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR CRANBERRY SEED OIL (UNII: 73KDS3BW5E) INGR NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT) INGR RASPBERRY SEED OIL (UNII: 9S8867952A) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR sodium hydroxide (UNII: 55X04QC32I) INGR PHYTATE SODIUM (UNII: 88496G1ERL) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR CUCUMBER (UNII: YY7C30VXJT) INGR CHAMOMILE (UNII: FGL3685T2X) INGR AVOCADO (UNII: SDS87L369F) INGR tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 207 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2015 Part 4 of 6 BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER MANDARIN
benzalkonium chloride liquidProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cetrimonium chloride (UNII: UC9PE95IBP) laurtrimonium chloride (UNII: A81MSI0FIC) dihydroxyethyl cocamine oxide (UNII: 8AR51R3BL5) glycereth-17 cocoate (UNII: 3057VPT0KC) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) triethyl citrate (UNII: 8Z96QXD6UM) TANGERINE (UNII: KH3E3096OO) tocopherol (UNII: R0ZB2556P8) ORANGE OIL (UNII: AKN3KSD11B) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-4000-5 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/15/2013 Part 5 of 6 TOY, TABLE AND HIGHCHAIR WIPES
cleansing (cold creams, cleansing lotions, liquids, and pads) clothProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR water (UNII: 059QF0KO0R) INGR glycerin (UNII: PDC6A3C0OX) INGR decyl glucoside (UNII: Z17H97EA6Y) INGR malic acid (UNII: 817L1N4CKP) INGR potassium sorbate (UNII: 1VPU26JZZ4) INGR gluconolactone (UNII: WQ29KQ9POT) INGR sodium benzoate (UNII: OJ245FE5EU) INGR DIRECT BLACK 19 (UNII: B91N7SNH1C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 25 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2015 Part 6 of 6 FOAMING DISH AND BOTTLE SOAP
bath soaps and detergents liquidProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR water (UNII: 059QF0KO0R) INGR cocamidopropyl hydroxysultaine (UNII: 62V75NI93W) INGR lauramine oxide (UNII: 4F6FC4MI8W) INGR decyl glucoside (UNII: Z17H97EA6Y) INGR sodium lauroyl sarcosinate (UNII: 632GS99618) INGR glycerin (UNII: PDC6A3C0OX) INGR methylisothiazolinone (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 89 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333E 01/01/2015 Labeler - KAS Direct LLC dba BabyGanics (002764605)