Label: KOLMED HAND SANITIZING WIPES- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 79517-001-01, 79517-001-02 - Packager: Passhion Inc
- 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 August 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
• in children less than 2 months of age
• on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water. Do not inhale
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours
- Directions
- Other information
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
3X STRONGER
Kills 99% OF COMMON GERMS*
COTTONY SOFT
NON-ALCOHOL FORMULA
Crisp Orange
GENTLE ON HANDS
EXTRA SOFT WIPE WITH ALOE
√ Kills 99% of many common harmful germs and bacteria*
√ Removes light soils and dirt from hands
√ Gentle on hands
√ Multi-layered Wipe. 3X Stronger vs. Paper Towel1
TO OPEN PACKAGE:
1. Pull out wipe from center of roll.
2. Next sheet pops up automatically.
3. Close lid to retain moisture.
STORAGE AND DISPOSAL:
Dispose of wipe in trash after use. Do not flush. Tightly close lid between uses to retain moisture.
Non refillable container. Do not reuse or refill this empty container.
Offer empty container for recycling. If recycling is not available, discard container in trash.
Questions or Comments?
Please visit www.kolmedusa.com.
Mon-Fri 9AM-6PM PST
Distributed by:
Passhion Inc
3192 Factory Dr, Pomona, CA, 91768
KOLMED is a registered trademark of Passhion Inc
Made in China
- Packaging
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INGREDIENTS AND APPEARANCE
KOLMED HAND SANITIZING WIPES
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79517-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.2 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79517-001-01 85 in 1 CANISTER 08/17/2020 1 4.41 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:79517-001-02 4 in 1 BOX 08/17/2020 2 85 in 1 CANISTER 2 4.41 g in 1 PACKAGE; 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 08/17/2020 Labeler - Passhion Inc (080618941)
