Label: AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET- dimethicone kit
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- NDC Code(s): 69968-0441-8, 69968-0593-1, 69968-0679-8
- Packager: Johnson & Johnson Consumer 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 6, 2023
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PRINCIPAL DISPLAY PANEL - Kit Container
Aveeno
Baby ®
bathtime solutions
baby & mommy gift setFOR BABY
Wash & Shampoo, 8 fl oz (236 mL)
Daily Moisture Lotion, 8 oz (227 g)
CALMING COMFORT ® Bath, 8 fl oz (236 mL)FOR MOMMY
Stress Relief Body Wash, 12 fl oz (354 mL)
Free Reusable Canvas BoxPEDIATRICIAN
Aveeno®
RECOMMENDED ®Naturally Nourishing Solutions for Precious Bathtime Moments
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INGREDIENTS AND APPEARANCE
AVEENO BABY BATHTIME SOLUTIONS BABY AND MOMMY GIFT SET
dimethicone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0593 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0593-1 1 in 1 CONTAINER 06/16/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 227 mL Part 2 1 BOTTLE 236 mL Part 3 1 BOTTLE 236 mL Part 4 1 BOTTLE 354 mL Part 5 1 TUBE 227 g Part 1 of 5 AVEENO BABY DAILY MOISTURE
dimethicone lotionProduct Information Item Code (Source) NDC:69968-0441 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 12 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETYL ALCOHOL (UNII: 936JST6JCN) OATMEAL (UNII: 8PI54V663Y) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0441-8 227 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2001 06/30/2020 Part 2 of 5 AVEENO BABY WASH AND SHAMPOO
baby shampoos solutionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR GLYCERYL OLEATE (UNII: 4PC054V79P) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR OATMEAL (UNII: 8PI54V663Y) INGR WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 236 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 06/01/2010 Part 3 of 5 AVEENO BABY CALMING COMFORT BATH
baby shampoos solutionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR GLYCERYL OLEATE (UNII: 4PC054V79P) INGR POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR OATMEAL (UNII: 8PI54V663Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 236 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 06/01/2010 Part 4 of 5 AVEENO STRESS RELIEF BODY WASH
bath soaps and detergents lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR OATMEAL (UNII: 8PI54V663Y) INGR GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) INGR EDETATE SODIUM (UNII: MP1J8420LU) INGR GLYCOL DISTEARATE (UNII: 13W7MDN21W) INGR QUATERNIUM-15 (UNII: E40U03LEM0) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR MYRISTYL ALCOHOL (UNII: V42034O9PU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 354 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 06/01/2008 Part 5 of 5 AVEENO BABY DAILY MOISTURE
dimethicone lotionProduct Information Item Code (Source) NDC:69968-0679 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 12 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PETROLATUM (UNII: 4T6H12BN9U) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETYL ALCOHOL (UNII: 936JST6JCN) OATMEAL (UNII: 8PI54V663Y) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0679-8 227 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/16/2019 Labeler - Johnson & Johnson Consumer Inc. (118772437)