LX0380 LYNX GLACIER FRESH ANTISEPTIC HAND AND BODY WASH 6380- chloroxylenol soap 
ABC Compounding Co., Inc.

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.

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LX0380 Lynx glacier fresh Antiseptic Hand & Body Wash 6380 drug facts and label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.3%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

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

Drug Facts Box OTC-Dosage & Administration Section

Drug Facts Box OTC-Inactive Ingredient Section

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1

LX0380 Lynx glacier fresh Antiseptic Hand & Body Wash 6380

product labelproduct image

LX0380 LYNX GLACIER FRESH ANTISEPTIC HAND AND BODY WASH 6380 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62257-380
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACID BLUE 25 (UNII: S2E15W6FSN)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ACID RED 1 (UNII: 3365R6427R)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62257-380-121000 mL in 1 BAG; Type 0: Not a Combination Product12/12/2022
2NDC:62257-380-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/12/2022
Labeler - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62257-380)

Revised: 6/2023
Document Id: fd8f9b33-2482-7a8c-e053-6294a90a7b52
Set id: efa3938f-64de-77ba-e053-2a95a90ac840
Version: 2
Effective Time: 20230607
 
ABC Compounding Co., Inc.