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NDC 76383-0055-01 Trolls grape scented hand sanitizer 0.015 g/100mL Details

Trolls grape scented hand sanitizer 0.015 g/100mL

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

Product Information

NDC	76383-0055
Product ID	76383-055_a7177742-6401-070d-e053-2a95a90a117e
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 grape scented hand sanitizer
Proprietary Name Suffix	1
Non-Proprietary Name	Chloroxylenol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.015
Active Ingredient Units	g/100mL
Substance Name	CHLOROXYLENOL
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 76383-0055-01 (76383005501)

Pricing Information	N/A
NDC Package Code	76383-055-01
Billing NDC	76383005501
Package	59 mL in 1 BOTTLE, PLASTIC (76383-055-01)
Marketing Start Date	2020-05-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a71786d0-7ca3-09c3-e053-2a95a90a9005 Details

Drug facts

SPL UNCLASSIFIED SECTION

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

Chloroxylenol 0.015%..... 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

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 6 use under adult supervision

Inactive ingredients

INACTIVE INGREDIENTS: WATER, GLYCERIN, COCETH-7, PPG-1-PEG-9 LAURYL GLYCOL ETHER, CARBOMER, SODIUM HYDROXIDE, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE (PARFUM).

MAY CONTAIN: RED 40, RED 33, BLUE 1, YELLOW 5.

Questions?

1-212-779-0544 weekdays

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TROLLS GRAPE SCENTED HAND SANITIZER 01

chloroxylenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76383-055
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.015 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 4 (UNII: X3W0AM1JLX)	0.0008 g in 100 mL
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)	0.3 mL in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.3 mL in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0003 g in 100 mL
GRAPEFRUIT JUICE (UNII: JQ9EK2H6BG)	0.05 mL in 100 mL
WATER (UNII: 059QF0KO0R)	92.1989 mL in 100 mL
CARBOMER 934 (UNII: Z135WT9208)	0.09 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	6.5 mL in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.045 mL in 100 mL

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76383-055-01	59 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	05/15/2020	05/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/15/2020	05/31/2023

Labeler - BBC GROUP limit (421270060)

Registrant - Townley Inc. (016956158)

Name	Address	ID/FEI	Business Operations
Establishment
BBC GROUP limit		421270060	manufacture(76383-055)

Revised: 6/2020

Document Id: a7177742-6401-070d-e053-2a95a90a117e

Set id: a71786d0-7ca3-09c3-e053-2a95a90a9005

Version: 1

Effective Time: 20200602