OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% (w/w)

OTC - PURPOSE SECTION

Antiseptic

For external use only.

Flammable, keep away from fire or flame.

Stop use and ask a doctor if irritation and redness develop; condition persists for more than 72 hours.

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

Wet hands thoroughly with product and allow to dry without wiping.

Water, glycerin, polysorbate 20, tocopheryl acetate, PEG-12 dimethicone, methylisothiazolinone, iodopropynyl butylcarbamate, fragrance, citric acid.

Store in a cool place.

Do not use in the eyes

Dodys Box with 24 Packets, each Packet with 48 Wipes NDC 77824-001-02

DodysBox

Dodys Main Packet, 48 Wipe packet NDC 77824-001-01

DodysPacket

Dodys Big Size Product NDC 77824-001

DodysLabel

DODYS WIPES
antiseptic hand sanitizer wipes cloth

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg

Ingredient Name	Strength
Inactive Ingredients
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77824-001-01	48 in 1 PACKET; Type 0: Not a Combination Product	06/26/2023
2	NDC:77824-001-02	24 in 1 BOX; Type 0: Not a Combination Product	06/26/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	06/26/2023

Labeler - Betone SA de CV (813262755)

Name	Address	ID/FEI	Business Operations
Establishment
Betone SA de CV		813262755	manufacture(77824-001) , pack(77824-001) , label(77824-001)