503BOU RX FRESH PURE HAND: Package Insert and Label Information

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.

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

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

Image of tube

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

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

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503BOU RX FRESH PURE HAND
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73864-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Butylene Glycol
TROLAMINE
Polysorbate 60
Isopropyl Myristate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73864-010-01 500 mL in 1 BOTTLE, PUMP None
2 NDC:73864-010-02 70 mL in 1 TUBE None
3 NDC:73864-010-04 30 PACKET100 PACKET in 1 CARTON contains a PACKET (73864-010-03)
3 NDC:73864-010-05 30 PACKET100 PACKET in 1 CARTON contains a PACKET (73864-010-03)
3 NDC:73864-010-03 1.2 mL in 1 PACKET This package is contained within a CARTON (73864-010-04) and a CARTON (73864-010-05)
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 Operations
Ester Co., Ltd. 688425766 manufacture (73864-010)

Revised: 04/2020 Salty Family Group Co., Ltd.

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