503BOU RX FRESH PURE HAND- alcohol gel

503BOU RX FRESH PURE HAND by

Drug Labeling and Warnings

503BOU RX FRESH PURE HAND by is a Otc medication manufactured, distributed, or labeled by Salty Family Group Co., Ltd., Ester Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: ALCOHOL 70.00 wt%

INACTIVE INGREDIENT

Inactive Ingredients:

Carbomer, Butylene Glycol, Triethanolamine, Polysorbate 60, Isopropyl Myristate,
Fragrance, Water

PURPOSE

Purpose: SANITIZER

WARNINGS

Warnings (500mL Bottle, 1.5mL*30pcs, 1.5mL*100pcs)

For external use only. Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Keep out of reach of children.

Warnings (70mL Tube)

For external use only.
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Replace the cap after use.
Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:
■ Hand sanitizer to decrease the bacteria on the skin.
■ Recommended for repeated use.

Directions

Directions:
■ Rub a dime sized drop into hands.

PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 500mL Bottle Pump

PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 70mL Tube

PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 1.2mL*30pcs

PACKAGE LABEL - 503BOU RX FRESH PURE HAND GEL 1.2mL*100pcs

INGREDIENTS AND APPEARANCE

503BOU RX FRESH PURE HAND 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73864-010
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Butylene Glycol (UNII: 3XUS85K0RA)
TROLAMINE (UNII: 9O3K93S3TK)
Polysorbate 60 (UNII: CAL22UVI4M)
Isopropyl Myristate (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73864-010-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2020
2	NDC: 73864-010-02	70 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2020
3	NDC: 73864-010-04	30 in 1 CARTON	03/01/2020
3	NDC: 73864-010-03	1.2 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 73864-010-05	100 in 1 CARTON	03/01/2020
4	NDC: 73864-010-03	1.2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/01/2020

Labeler - Salty Family Group Co., Ltd. (689057520)

Registrant - Salty Family Group Co., Ltd. (689057520)

Establishment
Name	Address	ID/FEI	Business Operations
Ester Co., Ltd.		688425766	manufacture(73864-010)