bebe bottoms Diaper Rash Creme Spray

bebe bottoms Diaper Rash Creme by

Drug Labeling and Warnings

bebe bottoms Diaper Rash Creme by is a Otc medication manufactured, distributed, or labeled by Frike Pharma AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BEBE BOTTOMS DIAPER RASH CREME- zinc oxide spray 
Frike Pharma AG

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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bebe bottoms Diaper Rash Creme Spray

Active ingredients 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

Keep out of reach of children

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

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

For external use only

When using this product

• do not get into eyes

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 information

Store at room temperature, below 77ºF

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

bebe Bottoms

Diaper Rash Creme Spray

10% Zinc Oxide

Skin Protectant

Prevents and Treats for Daily use

Net Wt. 1.7 OZ (50 mL)

BEBE BOTTOMS DIAPER RASH CREME 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83598-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALLYL ALCOHOL (UNII: 3W678R12M0)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
OLEIC ACID (UNII: 2UMI9U37CP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83598-001-01	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/28/2023	09/06/2023
2	NDC: 83598-001-02	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/28/2023	09/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	07/28/2023	09/06/2023

Labeler - Frike Pharma AG (485828425)

Revised: 9/2023

Document Id: 04b829ee-8ec2-2ccf-e063-6394a90a0676

34390-5

Set id: 018f8898-018d-9a31-e063-6394a90a3f37

Version: 2

Effective Time: 20230906