MEDI-HANDS- chloroxylenol soap

Medi-Hands by

Drug Labeling and Warnings

Medi-Hands by is a Otc medication manufactured, distributed, or labeled by Topmost Chemical & Paper Corporation, Betco corporation, Ltd., Betco Corpo, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Medi-Hands

​Active Ingredient

Chloroxylenol 0.375%

Medi-Hands

Uses

• ​​Antibacterial hand cleaner.
• Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Medi-Hands

Warnings

• For external use only.
• Avoid contact with eyes.
• Children under the age of 6 should be supervised by an adult when using this product.
• Discontinue use is irritation or redness develops.
• If irritation persists for more than 72 hours, consult a physician.
• KEEP OUT OF REACH OF CHILDREN.

Medi-Hands

Directions

• ​Read the entire label before using this product.
• ​Dispense 1-2 pumps of product onto wet palm.
• Lather and rinse hands with clean water

Medi-Hands

Inactive Ingredients

​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

Medi-Hands

Purpose

Antibacterial

Medi-Hands

Medi-Hands

KEEP OUT OF REACH OF CHILDREN

Medi-Hands Pearlized Antibacterial Skin Cleanser with PCMX Distributed by: TOPMOST CHEMICAL & PAPER CORP. 3394 Winchester Rd. Memphis, TN 38118 (901) 363-7278

14104-00_Topmost_MediHands

INGREDIENTS AND APPEARANCE

MEDI-HANDS 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68978-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL BENZOATE (UNII: N863NB338G)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYL ALCOHOL (UNII: Y4S76JWI15)
ETHYLENE OXIDE (UNII: JJH7GNN18P)
ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)
CHLOROACETIC ACID (UNII: 5GD84Y125G)
DIOXANE (UNII: J8A3S10O7S)
CALCIUM SILICATE (UNII: S4255P4G5M)
SODIUM FERROCYANIDE (UNII: 5HT6X21AID)
DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
ETHYL BUTYRATE (UNII: UFD2LZ005D)
MYRCENE (UNII: 3M39CZS25B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)
ETHYL ACETOACETATE (UNII: IZP61H3TB1)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
SODIUM CARBONATE (UNII: 45P3261C7T)
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68978-708-04	3780 mL in 1 JUG; Type 0: Not a Combination Product	05/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	05/06/2014

Labeler - Topmost Chemical & Paper Corporation (086944576)

Registrant - Betco corporation, Ltd. (005050158)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corpo, Ltd.		005050158	manufacture(68978-708) , pack(68978-708) , label(68978-708)