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| Product NDC Code | 69968-0712 | ||||
|---|---|---|---|---|---|
| Drug Name | Johnsons welcome baby gift set |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 349404, 1090577 |
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| Application Number | part347 | ||||
| Labeler Name | Johnson & Johnson Consumer Inc. | ||||
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 13%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions change wet and soiled diapers promptly cleanse the diaper area allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Aloe Barbadensis Leaf Extract, Glycerin, Tropolone, Tocopheryl Acetate, 1,2-Hexanediol, Caprylyl Glycol, Magnesium Sulfate, Potassium Hydroxide, Phenoxyethanol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Johnsons Welcome Baby Gift Set Zinc Oxide Desitin Daily Defense Zinc Oxide Diaper Rash Zinc Oxide .ALPHA.-TOCOPHEROL ACETATE 1,2-HEXANEDIOL CAPRYLYL GLYCOL MAGNESIUM SULFATE, UNSPECIFIED FORM POTASSIUM HYDROXIDE PHENOXYETHANOL ZINC OXIDE ZINC OXIDE WATER MINERAL OIL PETROLATUM YELLOW WAX DIMETHICONE SORBITAN SESQUIOLEATE MICROCRYSTALLINE WAX PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) ALOE VERA LEAF GLYCERIN TROPOLONE Johnsons Cottontouch Newborn Wash and Shampoo WATER COCAMIDOPROPYL BETAINE PEG-80 SORBITAN LAURATE DECYL GLUCOSIDE COTTON FIBER CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) PHENOXYETHANOL SODIUM BENZOATE COCO GLUCOSIDE GLYCERYL MONOOLEATE SODIUM HYDROXIDE ETHYLHEXYLGLYCERIN TETRASODIUM GLUTAMATE DIACETATE Johnsons Cottontouch Newborn Face and Body ISOPROPYL PALMITATE WATER GLYCERIN COTTON FIBER DIMETHICONE PHENOXYETHANOL CETEARYL OLIVATE SORBITAN OLIVATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) CAPRYLYL GLYCOL 1,2-HEXANEDIOL SODIUM HYDROXIDE ETHYLHEXYLGLYCERIN TROPOLONE Johnsons Hand and Face Wipes WATER GLYCERIN AMINO ACIDS, SILK CAPRYLYL GLYCOL POLYOXYL 40 HYDROGENATED CASTOR OIL SODIUM BENZOATE CITRIC ACID MONOHYDRATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - Kit Package JOHNSON'S ® welcome baby gift set set de regalo de bienvenida para bebé SAFETY TESTED FOR DELICATE SKIN INCLUDES: JOHNSON'S ® COTTONTOUCH® NEWBORN WASH & SHAMPOO 13.6 FL OZ (400 mL) ● JOHNSON'S ® HAND & FACE WIPES 25 CT 7.5 × 7.3 IN (190 × 185 MM) ● JOHNSON'S ® COTTONTOUCH ® NEWBORN FACE & BODY LOTION 13.6 FL OZ (400 mL) ● DESITIN ® DAILY DEFENSE DIAPER RASH CREAM 2 OZ (57 G) Principal Display Panel - Kit Package
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DESITIN ® Daily Defense Zinc Oxide Diaper Rash Cream Drug Facts
Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll-free 800-720-3843 or 215-273-8755 (collect) For more information on preventing and treating diaper rash, visit www.desitin.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not get into eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 20° to 25°C (68°F to 77°F) may stain clothing
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API