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NDC 73088-0202-11 HAND SANITIZER 62.5 g/100mL Details

HAND SANITIZER 62.5 g/100mL

HAND SANITIZER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by TUBBY TODD. The primary component is ALCOHOL.

Product Information

NDC	73088-0202
Product ID	73088-202_da339f1f-aaa8-3c5b-e053-2995a90acaff
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	HAND SANITIZER
Proprietary Name Suffix	CITRUS
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	62.5
Active Ingredient Units	g/100mL
Substance Name	ALCOHOL
Labeler Name	TUBBY TODD
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73088-0202-11 (73088020211)

Pricing Information	N/A
NDC Package Code	73088-202-11
Billing NDC	73088020211
Package	59 mL in 1 BOTTLE (73088-202-11)
Marketing Start Date	2019-12-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 26dfb9e4-3021-4a12-8b40-0383dbebc68c Details

ACTIVE INGREDIENTS

DENATURED DEHYDRATED ALCOHOL 40B 62.5%

PURPOSE

ANTISEPTIC

USES

• For hand washing to decrease bacteria on skin.

WARNINGS

• For external use only. Flammable. Keep away from sources of fire or flame.

• When using this product Do not use near eyes. In case of contact, rinse eyes thoroughly with water.

• Stop use and ask a doctor if skin irritation develops.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, seek medical advice or contact a Poison Control Center immediately.

DIRECTIONS

Apply onto palm of hand.
Cover hands with product by thoroughly rubbing and allow to air dry without wiping. Use undiluted.
Supervise children under 6 years
Not recommended for infants

OTHER INFORMATION

Store below 86°F / 30°C
Keep out of direct sunlight.

INACTIVE INGREDIENT

WATER, GLYCERIN, CITRUS AURANTIUM DULCIS (SWEET ORANGE) OIL, POLYSORBATE 20, CITRUS PARADISI (GRAPEFRUIT) OIL, ALLANTOIN, COCOS NUCIFERA (COCONUT) OIL, ORGANIC ROSA CANINA FRUIT OIL, PANTHENOL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, ALOE BARBADENSIS LEAF JUICE, ARGANIA SPINOSA (ARGAN) OIL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER CITRUS

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73088-202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ORANGE OIL (UNII: AKN3KSD11B)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALLANTOIN (UNII: 344S277G0Z)
COCONUT OIL (UNII: Q9L0O73W7L)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
PANTHENOL (UNII: WV9CM0O67Z)
JOJOBA OIL (UNII: 724GKU717M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGAN OIL (UNII: 4V59G5UW9X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73088-202-11	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/04/2019

Labeler - TUBBY TODD (052545299)

Name	Address	ID/FEI	Business Operations
Establishment
Health Specialty		794053863	manufacture(73088-202)

Revised: 3/2022

Document Id: da339f1f-aaa8-3c5b-e053-2995a90acaff

Set id: 26dfb9e4-3021-4a12-8b40-0383dbebc68c

Version: 4

Effective Time: 20220314