503BOU RX FRESH PURE HAND- alcohol gel
Salty Family Group Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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

Image of bottle

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

Image of tube

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

Image of carton

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

Image of carton

503BOU RX FRESH PURE HAND
alcohol gel

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73864-010-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2020	03/01/2021
2	NDC:73864-010-02	70 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2020	03/01/2021
3	NDC:73864-010-04	30 in 1 CARTON	03/01/2020	03/01/2021
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	03/01/2021
4	NDC:73864-010-03	1.2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/01/2020	03/01/2021

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

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

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

Revised: 11/2021

Document Id: e8572a30-3e7b-40ea-bea5-475b8ee33bbd

Set id: 115ade84-a53e-4c43-a9f3-1b4583bda1c3

Version: 2

Effective Time: 20211104

Salty Family Group Co., Ltd.