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NDC 76383-0050-01 Trolls strawberry scented hand sanitizer 62 g/100mL Details

Trolls strawberry scented hand sanitizer 62 g/100mL

Trolls strawberry scented hand sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by BBC GROUP limit. The primary component is ALCOHOL.

Product Information

NDC	76383-0050
Product ID	76383-050_a6dc168e-1ccb-2034-e053-2a95a90af365
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	Trolls strawberry scented hand sanitizer
Proprietary Name Suffix	01
Non-Proprietary Name	alochol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	62
Active Ingredient Units	g/100mL
Substance Name	ALCOHOL
Labeler Name	BBC GROUP limit
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	n/a

Package

Package Images

NDC 76383-0050-01 (76383005001)

Pricing Information	N/A
NDC Package Code	76383-050-01
Billing NDC	76383005001
Package	59 mL in 1 BOTTLE, PLASTIC (76383-050-01)
Marketing Start Date	2020-05-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a6dc168e-1ccc-2034-e053-2a95a90af365 Details

Drug facts

SPL UNCLASSIFIED SECTION

Active ingredient .............purpose

alcohol Denate: 70%(v/v)..... Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only-hands

keep out of eyes- avoid contact with broken skin.

Keep away from fire.

Stop use and ask a dosctor if irritation or radness develops

Do not inhale or ingest. If swallowed, get medical help or contact a poison control right away.

Direction

Rub a dime sized drop into hands.

For children under 8 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENTS: WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ c10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.

MAY CONTAIN: FD&C RED 40, D&C RED 33, FD&C BLUE 1, FD&C YELLOW 5.

Questions?

1-212-779-0544 weekdays

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TROLLS STRAWBERRY SCENTED HAND SANITIZER 01

alochol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76383-050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)	0.16 g in 100 mL
WATER (UNII: 059QF0KO0R)	37.2397 g in 100 mL
STRAWBERRY (UNII: 4J2TY8Y81V)	0.2 g in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.2 mL in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.2 mL in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.0002 g in 100 mL
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	0.0001 g in 100 mL

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76383-050-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/26/2020	05/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/26/2020	05/31/2024

Labeler - BBC GROUP limit (421270060)

Registrant - Townley Inc. (016956158)

Name	Address	ID/FEI	Business Operations
Establishment
BBC Group limit		421270060	manufacture(76383-050)

Revised: 5/2020

Document Id: a6dc168e-1ccb-2034-e053-2a95a90af365

Set id: a6dc168e-1ccc-2034-e053-2a95a90af365

Version: 1

Effective Time: 20200530