CLORALEN TM ANTIBACTERIAL WIPES- benzalkonium chloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

INDELPA, S.A DE C.V

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial Hand sanitizer to help reduce bacteria on the skin If you are allergic to any of the ingredients If irritation or rash develops and continues for more than 72 hours - wet hands throughly with product and allow to dry. -discard wipe in trash receptacle after use. Do not flush - chuldren under 6 years af age should be supervised whe using this product

Authorization status:

OTC monograph not final

Summary of Product characteristics

CLORALEN TM ANTIBACTERIAL WIPES- BENZALKONIUM CHLORIDE LIQUID
INDELPA, S.A DE C.V
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
Antibacterial
BENZALKONIUM, CHLORIDE 0.125%
Hand sanitizer to help reduce bacteria on the skin
For external use only.
If you are allergic to any of the ingredients
Do not get into eyes.
If contact occurs, rinse throughly with water
If irritation or rash develops and continues for more than 72 hours
If irritation or rash develops and continues for more than 72 hours
If swallowed, get medical help or contact a Poison Control Center
right away
- wet hands throughly with product and allow to dry.
-discard wipe in trash receptacle after use. Do not flush
- chuldren under 6 years af age should be supervised whe using this
product
water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate,
fragrance,
methylchloroisothiazolinone / methylisothiazolinone, aloe vera
extract, tetrasodium
EDTA, citric acid, acetate D alpha- tocopherol
Topical admistration
CLORALEN TM ANTIBACTERIAL WIPES
benzalkonium chloride liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70697-802
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.125 mg
in 100 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
0.01 mg in 100 mg
EDETATE SODIUM (UNII: MP1J8420LU)
0.03 mg in 100 mg
WATER (UNII: 059QF0KO0R)
98.567 mg
in 100 mg
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII:
0.1 mg in 100 mg
INDELPA, S.A DE C.V
15O9QS218W)
0.1 mg in 100 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X)
0.05 mg in 100 mg
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
0.018 mg in 100 mg
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
0.1 mg in 100 mg
PO