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NDC 72849-0101-11 LITTLE BUBS DIAPER 15.25 g/100g Details

LITTLE BUBS DIAPER 15.25 g/100g

LITTLE BUBS DIAPER is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by LITTLE BUBS COMPANY PTY LTD. The primary component is ZINC OXIDE.

Product Information

NDC	72849-0101
Product ID	72849-101_df267919-10c0-594f-e053-2995a90a7bbb
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	LITTLE BUBS DIAPER
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	15.25
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	LITTLE BUBS COMPANY PTY LTD
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72849-0101-11 (72849010111)

Pricing Information	N/A
NDC Package Code	72849-101-11
Billing NDC	72849010111
Package	350 g in 1 JAR (72849-101-11)
Marketing Start Date	2019-07-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9a720d23-bacd-4955-a1ca-d05ad013dd3b Details

ACTIVE INGREDIENT

ZINC OXIDE 15.25%

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 AVOID CONTACT WITH THE EYES
STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYS
KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION
IF SWALLOWED, SEEK MEDICAL HELP OR CALL PIOSON CONTROL CENTER IMMEDIATELY

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION
IF SWALLOWED, SEEK MEDICAL HELP OR CALL PIOSON CONTROL CENTER IMMEDIATELY

DIRECTIONS

REMOVE SEAL FROM CONTAINER PRIOR TO USE
CHANGE WET AND SOILED DIAPER IMMEDIATELY
CLEANSE THE DIAPER AREA AND ALLOW TO DRY
PUSH BUTTON TO ACCESS CREAM. SWEEP THE APPLICATOR BRUSH MOVING THE BRISTLES BACK AND FORTH IN A SEMI-CIRCLE LOADING CREAM ONTO YOUR DIAPER BRUSH AS REQUIRED
APPLY CREAM LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE AND ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD OF TIME, SUCH AS BEDTIME
RETURN YOUR DIAPER BRUSH TO ITS CENTER CAVITY AND CLOSE THE LID. ONCE BABY HAS BEEN SAFELY SET DOWN, USE A BABY WIPE OR TISSUE TO SPOT CLEAN YOUR DIAPER BRUSH IF REQUIRED.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE 20C TO 27C (68F TO 80F)
USE WITH INFANTS, CHILDREN AND ADULTS

INACTIVE INGREDIENTS

CERA ALBA (BEESWAX), CYCLOPENTASILOXANE, DISTEARDIMONIUM HECTORITE, LANOLIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MICROCRYSTALLINE WAX, OLEA EUROPAEA (OLIVE) OIL, ORGANIC ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT, ORGANIC CALENDULA OFFICINALIS (CALENDULA) FLOWER EXTRACT, ORGANIC MATRICARIA RECUTITA (CHAMOMILE) FLOWER EXTRACT, OZOKERITE, PARAFFIN WAX, POLYSORBATE 60, PROPYLENE CARBONATE, SORBITAN SESQUIOLEATE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LITTLE BUBS DIAPER

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72849-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
LANOLIN (UNII: 7EV65EAW6H)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
CERESIN (UNII: Q1LS2UJO3A)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72849-101-11	350 g in 1 JAR; Type 0: Not a Combination Product	07/05/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/05/2019

Labeler - LITTLE BUBS COMPANY PTY LTD (890711880)

Revised: 5/2022

Document Id: df267919-10c0-594f-e053-2995a90a7bbb

Set id: 9a720d23-bacd-4955-a1ca-d05ad013dd3b

Version: 4

Effective Time: 20220516