Label: WET WIPES- benzalkonium chloride swab
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Contains inactivated NDC Code(s)
NDC Code(s): 71198-001-01, 71198-001-02, 71198-001-03, 71198-001-04, view more71198-001-05, 71198-001-06, 71198-001-07, 71198-001-08, 71198-001-09, 71198-001-10 - Packager: HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Use
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Warnings
For external use only.
Do not use
over large areas of the body
if you are allergic to any of the ingredients
when using this product,avoid contact with eyes and face.
If contact occurs,flush thoroughly with water.
Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.
- Directions
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WET WIPES
benzalkonium chloride swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71198-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2-BROMO-2-NITROETHANOL (UNII: FA22WV2B2Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) COPPER TRIETHANOLAMINE (UNII: YBM44X0B6H) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71198-001-01 10 in 1 PACKAGE 02/13/2017 1 0.042 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:71198-001-02 15 in 1 PACKAGE 02/13/2017 2 0.06 g in 1 POUCH; Type 0: Not a Combination Product 3 NDC:71198-001-03 30 in 1 PACKAGE 02/13/2017 3 0.126 g in 1 POUCH; Type 0: Not a Combination Product 4 NDC:71198-001-05 80 in 1 PACKAGE 02/13/2017 4 0.336 g in 1 POUCH; Type 0: Not a Combination Product 5 NDC:71198-001-04 50 in 1 PACKAGE 02/13/2017 5 0.21 g in 1 POUCH; Type 0: Not a Combination Product 6 NDC:71198-001-06 100 in 1 PACKAGE 02/13/2017 6 0.42 g in 1 POUCH; Type 0: Not a Combination Product 7 NDC:71198-001-07 1200 in 1 PACKAGE 02/13/2017 7 5.04 g in 1 POUCH; Type 0: Not a Combination Product 8 NDC:71198-001-08 50 in 1 BOTTLE 02/13/2017 8 0.21 g in 1 POUCH; Type 0: Not a Combination Product 9 NDC:71198-001-09 80 in 1 BOTTLE 02/13/2017 9 0.336 g in 1 POUCH; Type 0: Not a Combination Product 10 NDC:71198-001-10 100 in 1 BOTTLE 02/13/2017 10 0.42 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/13/2017 Labeler - HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD (543255067) Establishment Name Address ID/FEI Business Operations HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD 543255067 manufacture(71198-001)