BEKLYN ABSOLUTE PURIFYING HAND GEL- titanium dioxide, hypochlorous acid gel

Beklyn Absolute Purifying Hand Gel by

Drug Labeling and Warnings

Beklyn Absolute Purifying Hand Gel by is a Otc medication manufactured, distributed, or labeled by MY Corp.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

titanium dioxide, hypochlorous acid

INACTIVE INGREDIENT

Carbomer, Foeniculum Vulgare Fruit Extract, Maltitol, Polygonum Tinctorium Leaf Extract, Sorbitol, Triethanolamine, Water

PURPOSE

Hand sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

• Squeeze enough product in your palm to cover hands and rub hands together until dry.
• For children under 6 years use adult supervision
• Not recommended for infants

WARNINGS

For external use only. 

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs develop and persist for more than 72 hours.

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEKLYN ABSOLUTE PURIFYING HAND GEL 
titanium dioxide, hypochlorous acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71544-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.03 g  in 300 mL
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.024 g  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
FOENICULUM VULGARE FRUIT (UNII: J5W36Y5WG8)
MALTITOL (UNII: D65DG142WK)
PERSICARIA TINCTORIA LEAF (UNII: FU6582QMPV)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71544-0004-1	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/15/2020

Labeler - MY Corp.,Ltd (688202781)

Registrant - MY Corp.,Ltd (688202781)

Establishment
Name	Address	ID/FEI	Business Operations
MY Corp.,Ltd		688202781	manufacture(71544-0004) , label(71544-0004) , pack(71544-0004)