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Johnsons baby care essentials gift set - Medication Information

Product NDC Code 69968-0713
Drug Name

Johnsons baby care essentials gift set

Type Brand
Dosage Form KIT
Application Number M016
Labeler Name Kenvue Brands LLC
Packages
Package NDC Code Description
69968-0713-9 1 kit in 1 package (69968-0713-9) * 100 ml in 1 bottle * 100 ml in 1 bottle * 1 tube in 1 carton (69968-0061-1) / 28 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 40%

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 paste 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 Petrolatum, Cod Liver Oil, Lanolin, Talc, Glycerin, Sorbitan Sesquioleate, Beeswax, Tocopheryl Acetate, Fragrance

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 Baby Care Essentials Gift Set Zinc Oxide Desitin Maximum Strength Diaper Rash Zinc Oxide PETROLATUM COD LIVER OIL LANOLIN TALC GLYCERIN SORBITAN SESQUIOLEATE YELLOW WAX .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE Johnsons Head To Toe Wash WATER COCAMIDOPROPYL BETAINE PEG-80 SORBITAN LAURATE GLYCERIN PEG-150 PENTAERYTHRITYL TETRASTEARATE PPG-2 HYDROXYETHYL COCAMIDE PHENOXYETHANOL SODIUM METHYL COCOYL TAURATE SODIUM BENZOATE DECYL GLUCOSIDE CITRIC ACID MONOHYDRATE ETHYLHEXYLGLYCERIN Johnsons Baby PHENOXYETHANOL POLYSORBATE 20 MAGNESIUM ALUMINUM SILICATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) P-ANISIC ACID SODIUM HYDROXIDE XANTHAN GUM ETHYLHEXYLGLYCERIN TITANIUM DIOXIDE WATER GLYCERIN ISOPROPYL PALMITATE STEARIC ACID GLYCERYL MONOSTEARATE CETYL ALCOHOL COCONUT OIL DIMETHICONE CETOSTEARYL ALCOHOL

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 ® baby care essentials productos esenciales para el cuidado del bebé value pack all products are TSA compliant! Includes JOHNSON'S ® HEAD-TO TOE ® wash and shampoo 3.4 FL OZ (100 mL) ● JOHNSON'S ® baby lotion 3.4 FL OZ (100 mL) DESITIN ® Maximum Strength Zinc Oxide Diaper Rash Paste 1 OZ (28 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 ® Maximum Strength Zinc Oxide Diaper Rash Paste 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°C 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