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NDC 72520-0118-48 NUVALU HAND SANITIZER GUAVA BURST 1OZ 70 mL/100mL Details

NUVALU HAND SANITIZER GUAVA BURST 1OZ 70 mL/100mL

NUVALU HAND SANITIZER GUAVA BURST 1OZ is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by JC SALES. The primary component is ALCOHOL.

Product Information

NDC	72520-0118
Product ID	72520-118_bd4ed746-f760-890a-e053-2a95a90a128c
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	NUVALU HAND SANITIZER GUAVA BURST 1OZ
Proprietary Name Suffix	n/a
Non-Proprietary Name	ETHYL ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	JC SALES
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72520-0118-48 (72520011848)

Pricing Information	N/A
NDC Package Code	72520-118-48
Billing NDC	72520011848
Package	29 mL in 1 BOTTLE, PLASTIC (72520-118-48)
Marketing Start Date	2021-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bd4edc57-404b-64c7-e053-2a95a90aa46e Details

Drug Facts Active Ingredient

Ethyl Alcohol 70 percent

Purpose

Antimicrobial

Features

To decrease bacteria on the skin that could cause disease.
Recommended for repeated use.
Use anywhere without water.

Directions

Wet hands thoroughly with product and rub until dry without wiping.
For children under 6, use only under adult supervision.
Not recommended for infants.

When using this product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
Do not inhale or ingest.
Avoid contact with broken skin.

Other information

Do not store above 105 Fahrenheit
May discolor some fabrics
Harmful to wood finishes and plastics

Warnings

For external use only.
Flammable. Keep away from heat and flame.
Discontinue if skin becomes irritated and ask a doctor.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Inactive Ingredients

Water, Carbomer, Fragrance, Glycerin, Propylene Glycol, Triethanolamine, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, FD&C Red No.40, FD&C Yellow No.5

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUVALU HAND SANITIZER GUAVA BURST 1OZ

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72520-118
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72520-118-48	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/01/2021

Labeler - JC SALES (610969578)

Registrant - JC SALES (610969578)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(72520-118)

Revised: 3/2021

Document Id: bd4ed746-f760-890a-e053-2a95a90a128c

Set id: bd4edc57-404b-64c7-e053-2a95a90aa46e

Version: 1

Effective Time: 20210311