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

Purpose

Skin protectant

Description

Drug Facts


Medication Information

Warnings

For external use only

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

Skin protectant

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.
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

Description

Drug Facts

Questions?

call 1-866-923-4914

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).
Active Ingredient

Zinc oxide 10%

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

Warnings

For external use only

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

Skin protectant

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.
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

Questions?

call 1-866-923-4914

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).
Active Ingredient (Active ingredient)

Zinc oxide 10%

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)