ANTIMICROBIAL HAND SANITIZING MANGO SCENTED- ethyl alcohol lotion
HandsFree

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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Antimicrobial Hand Sanitizing Lotion Mango Scented

Active Ingredient:

Ethyl Alcohol 62 percent

For handwashing to decrease bacteria on the skin
Recommended for repeated use

Purpose:

Antiseptic

For external use only. Flammable. Keep away from heat and flame.

When using this product

Do not use in eyes. In case of contact with eyes, flush thoroughly with water.
Avoid contact with broken skin.

Discontinue use if skin irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.
Children under 6, use only under adult supervision
Not recommended for infants

Other Information

Do not store above 105 degrees F
May discolor some fabrics

Benzophenone-4, Carbomer, Fragrance, Glycerin, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate, Water

ANTIMICROBIAL HAND SANITIZING MANGO SCENTED
ethyl alcohol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49725-926
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SULISOBENZONE (UNII: 1W6L629B4K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49725-926-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/28/2009

Labeler - HandsFree (837204945)

Registrant - Xiamen Royaltech Packaging Co., Ltd. (529325521)

Name	Address	ID/FEI	Business Operations
Establishment
Xiamen Royaltech Packaging Co., Ltd.		529325521	manufacture(49725-926)

Revised: 1/2021

Document Id: b8511dd5-d363-85fe-e053-2a95a90a43aa

Set id: 204d2ba7-b07e-4ac6-b4f4-bb5c915d66ed

Version: 4

Effective Time: 20210107

HandsFree