HANDSOAP- chlorxylenol soap

Handsoap by

Drug Labeling and Warnings

Handsoap by is a Otc medication manufactured, distributed, or labeled by YOYO LIP GLOSS, INC, Guangzhou Opseve Cosmetics Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Chloroxylenol 0.30% v/v Purpose: Antibacterial

Antibacterial, Antibacterial Hand Soap

INDICATIONS & USAGE

For handwashing to decrease bacteria on the skin

WARNINGS

For external use only. When using this product, avoid contact with eyes. In case of eye contact, flush with water.

WHEN USING

Keep out of reach of children

If swallowed, get medical help or contact poison control center right away

STOP USE

Stop use and ask doctor if irritation and redness develop

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Wet hands as needed

Lather vigourously for at least 15 seconds

Rinse and dry thoroughly

INACTIVE INGREDIENT

water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, fragrance, citric acid, peg-15 distearate, methylchloroisothiazolinone, methylisothiazolinone, may contain: titanium dioxide (Ci 77891), Fd&c Blue No. 1 (Ci 42090), D&c Yellow No. 10 (Ci 47005), D&c Red No. 28 (Ci 45410), Iron Oxides (Ci 77492), Mica (Ci 77019)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HANDSOAP 
chlorxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70611-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MICA (UNII: V8A1AW0880)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70611-555-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2020

Labeler - YOYO LIP GLOSS, INC (828881792)

Registrant - YOYO LIP GLOSS, INC (828881792)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Opseve Cosmetics Co., LTD		421275457	label(70611-555) , pack(70611-555) , manufacture(70611-555)