BEBE BOTTOMS- zinc oxide spray

Bebe Bottoms by

Drug Labeling and Warnings

Bebe Bottoms by is a Otc medication manufactured, distributed, or labeled by TARO PHARMACEUTICALS U.S.A., INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

SPL UNCLASSIFIED SECTION

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

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)

INGREDIENTS AND APPEARANCE

BEBE BOTTOMS 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-5318
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C14-22 ALCOHOLS (UNII: B1K89384RJ)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CHAMOMILE (UNII: FGL3685T2X)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
GLYCERIN (UNII: PDC6A3C0OX)
OLEIC ACID (UNII: 2UMI9U37CP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-5318-3	1 in 1 CARTON	12/01/2023
1		50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 51672-5318-7	1 in 1 CARTON	12/01/2023
2		100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/01/2023

Labeler - TARO PHARMACEUTICALS U.S.A., INC. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	manufacture(51672-5318)