SOFTIS- benzalkonium chloride, polyaminopropil biguanide cloth

SOFTIS by

Drug Labeling and Warnings

SOFTIS by is a Otc medication manufactured, distributed, or labeled by Betone, S.A de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Belzalkonium chloride 0.12 % w/w. Purpose: Antiseptic

Polyaminopropyl Biguanide 0.5% w/w Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, glycerin, disodium cocoamphodiacetate, polysorbate 20, decyl glucoside, iodopropynyl butyñcarmate, methylisothiazolinone, PEF- 12 dimethicone, fragrance, aleo vera and citric acid.

Package Label - Principal Display Panel

PDP 150 g NDC: 77824-002-02

INGREDIENTS AND APPEARANCE

SOFTIS 
benzalkonium chloride, polyaminopropil biguanide cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77824-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g  in 100 mL
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET) (POLYAMINOPROPYL BIGUANIDE - UNII:DT9D8Z79ET)	POLYAMINOPROPYL BIGUANIDE	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE PEG-7 PANTHENYL PHOSPHATE (12 PANTHENOL) (UNII: 7MA9F33W92)	0.12 mL  in 100 mL
ABRONIA FRAGRANS FLOWER (UNII: XAV1S68QBA)	0.1 mL  in 100 mL
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)	0.17 mL  in 100 mL
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)	0.2 mL  in 100 mL
ALOE VERA FLOWER (UNII: 575DY8C1ER)	0.08 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.04 mL  in 100 mL
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	0.17 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)	0.6 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77824-004-01	150 mL in 1 POUCH; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Betone, S.A de C.V. (813262755)

Establishment
Name	Address	ID/FEI	Business Operations
Betone, S.A de C.V.		813262755	manufacture(77824-004) , pack(77824-004) , label(77824-004)