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Johnsons first touch baby gift set - Medication Information

Product NDC Code 69968-0906
Drug Name

Johnsons first touch baby gift set

Type Brand
Dosage Form KIT
Application Number M016
Labeler Name Kenvue Brands LLC
Packages
Package NDC Code Description
69968-0906-9 1 kit in 1 package (69968-0906-9) * 400 ml in 1 bottle * 400 ml in 1 bottle * 1 tube in 1 carton (69968-0848-2) / 57 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, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, 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 First Touch Baby Gift Set Zinc Oxide Desitin Maximum Strength Zinc Oxide Diaper Rash Zinc Oxide PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PETROLATUM COD LIVER OIL LANOLIN STARCH, CORN 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 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 World’s # 1 Baby & Child Care Brand* Johnson’s® baby first touch gift set value pack Step 1 Gently Cleanse Step 2 Moisturize Baby’s Delicate Skin Healthy Skin = Happier Baby Our 2 Step bath time routine formulas designed to work together! a selection of gentle products to cleanse, moisturize, and care for baby’s delicate skin Hypoallergenic, no parabens or dyes *Source Euromonitor International Limited; Beauty and Personal Care 2023 ed. as per Baby and Child-Specific Products category; all retail channels; value sales at RSP; 2022 data. Includes: JOHNSON’S® HEAD-TO-TOE® wash & shampoo 13.6 FL OZ (400 mL) DESITIN® Maximum Strength Zinc Oxide Diaper Rash Cream 2 OZ (57 g) JOHNSON’S® baby lotion 13.6 FL OZ (400 mL) Johnsons_01

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 Drug Facts Distributed by: Kenvue Brands LLC Summit, NJ 07901

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)

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