bebe bottoms Diaper Rash Creme Spray

Manufacturer
Frike Pharma AG
Effective date
2023-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:52

Label at a glance#

Productbebe bottoms Diaper Rash Creme
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Zinc Oxide 10%

OTC - PURPOSE SECTION

Purpose Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

  • If Swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

INDICATIONS & USAGE SECTION

Stop use abd contact a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and reoccur within a few days
  • not to be applied over deep or puncture wounds, infection or laceration.

WARNINGS SECTION

Warnings

For external use only

When using this product

  • do not get into eyes

DOSAGE & ADMINISTRATION SECTION

Directions

Shake well before use

Change wet and soiled diapers

Cleanse the diaper area and allow to dry

apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolongued

OTHER SAFETY INFORMATION

other information

Store at room temperature, below 77ºF

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

allyl-alcohols, alkyl glucoside, calendula officinalis flower extract, caprylyl glycol, caprylhydroxamic acid, chamomilla recutita (matricaria) flower extract, coco-caprylate/caprate, cocoglycerides, glycerin, oleic acid, potassium sorbate, propylene glycol, silica, sodium benzoate, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bebe Bottoms

Diaper Rash Creme Spray

10% Zinc Oxide

Skin Protectant

Prevents and Treats for Daily use

Net Wt. 1.7 OZ (50 mL)

diaper rash creme spraydiaper rash creme spray

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83598-00183598-001-01, 83598-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
04b829ee-8ec2-2ccf-e063-6394a90a0676018f8898-018d-9a31-e063-6394a90a3f372023-09-06WarningsExact identifier
spl set id: 018f8898-018d-9a31-e063-6394a90a3f37

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.