Bebe Bottoms Spray
FDA Label NDC 51672-5318

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals U.s.a., Inc. for the product Bebe Bottoms (NDC 51672-5318). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and contact a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Taro Pharmaceuticals U.S.A., Inc.,
Hawthorne, NY 10532 PRODUCT OF NETHERLANDS

Active Ingredient

Zinc oxide 10%

Purpose

Skin protectant

Uses

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

Warnings

For external use only

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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

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

Questions?

call 1-866-923-4914

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)

Principal Display Panel (100 mL Bottle Carton)

Principal Display Panel (100 mL Bottle Carton)

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