503BOU RX PURE AND SAFE SANITIZER by Salty Family Group Co., Ltd. / WHAIN COSMETIC

503BOU RX PURE AND SAFE SANITIZER by

Drug Labeling and Warnings

503BOU RX PURE AND SAFE SANITIZER by is a Otc medication manufactured, distributed, or labeled by Salty Family Group Co., Ltd., WHAIN COSMETIC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

503BOU RX PURE AND SAFE SANITIZER- alcohol spray 
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

ALCOHOL 70%

INACTIVE INGREDIENTS

Water, Glycerin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Artemisia Princeps Extract, Fragrance

PURPOSE

SANITIZER

WARNINGS

For external use only. Flammable. Keep away from heat or flame.
Supervise children under 6 years old when using this product to avoid swallowing.
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Do not use
on children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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

Directions

■ Spray enough onto palm. Rub hands together until dry.

Other information

Store between 1-30C (34-86F)
Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottleImage of bottle

503BOU RX PURE AND SAFE SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73864-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73864-020-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/202003/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/202003/01/2021
Labeler - Salty Family Group Co., Ltd. (689057520)
Registrant - Salty Family Group Co., Ltd. (689057520)
Establishment
NameAddressID/FEIBusiness Operations
WHAIN COSMETIC557837595manufacture(73864-020)

Revised: 11/2021