Bebe Bottoms™

Bebe Bottoms™
SPL v4
SPL
SPL Set ID eb8512db-f8a9-432c-8779-2971411ce43d
Route
TOPICAL
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (100 mg)
Inactive Ingredients
C14-22 Alcohols C12-20 Alkyl Glucoside Calendula Officinalis Flower Caprylyl Glycol Caprylhydroxamic Acid Chamomile Cocoyl Caprylocaprate Coco-glycerides Glycerin Oleic Acid Potassium Sorbate Propylene Glycol Silicon Dioxide Sodium Benzoate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Drug Facts

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Drug Facts

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children

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

For external use only

Directions
  • shake well before use
  • change wet and soiled diapers promptly
  • 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 prolonged.
Questions?

call 1-866-923-4914

Active Ingredient

Zinc oxide 10%

Other Information

Store at room temperature, below 77°F.

Inactive Ingredients

alkyl-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

When Using This Product
  • do not get into eyes
Stop Use and 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 lacerations
Principal Display Panel 100 Ml Bottle Carton

bébé

BOTTOMS

DIAPER RASH

CRÈME SPRAY

10% ZINC OXIDE

SKIN PROTECTANT

PREVENTS & TREATS

FOR DAILY USE

NET WT. 3.4 OZ (100 mL)


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children

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

Skin protectant

Warnings

For external use only

Directions
  • shake well before use
  • change wet and soiled diapers promptly
  • 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 prolonged.
Questions?

call 1-866-923-4914

Active Ingredient (Active ingredient)

Zinc oxide 10%

Other Information (Other information)

Store at room temperature, below 77°F.

Inactive Ingredients (Inactive ingredients)

alkyl-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

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Contact A Doctor If (Stop use and 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 lacerations
Principal Display Panel 100 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton)

bébé

BOTTOMS

DIAPER RASH

CRÈME SPRAY

10% ZINC OXIDE

SKIN PROTECTANT

PREVENTS & TREATS

FOR DAILY USE

NET WT. 3.4 OZ (100 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)