OTC Medication Information: SafeHands Hand Sanitizer Clean Linen

SAFEHANDS HAND SANITIZER CLEAN LINEN- benzalkonium chloride liquid
Safehands Distribution Ne, LLC

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.

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

To decrease bacteria on the skin

Warnings

For external use only.

Keep out of reach of children.

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

Do not use in eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if skin/eye irritation develops.

Directions

Liberally apply product to skin by gently massaging until

absorbed. Supervise children in the use of this product.

Other Information

• Avoid extreme temperatures.

Inactive Ingredients

Water, Cocamidolpropyl PG-Dimonium Chloride Phospate,

Propylene glycol, Triethylene glycol, Polysorbate-20, Fragrance

Package Labeling

safeHands®
Hand Sanitizer

kills 99.9% of common germs

CLEAN LINEN

MOISTURIZING & FOAMING

ALCOHOL-FREE FORMULA

1.75 fl oz (52 mL)

NDC 60867-152-02

Manufactured for

safeHands Distribution NE

35 Post Oak Office Park, Suite 3505

Wilbraham, MA 01095

Call toll free

1-866-748-9990

SAFEHANDS.COM

1.75 fl oz

152-02 52mL Btl
(click image for full-size original)

7 fl oz

152-07 200mL Btl
(click image for full-size original)

18 fl oz

152-18 500mL Btl
(click image for full-size original)

1000 mL

152-32 1000mL Btl
(click image for full-size original)

res

SAFEHANDS HAND SANITIZER CLEAN LINEN
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60867-152
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
PROPYLENE GLYCOL
TRIETHYLENE GLYCOL
POLYSORBATE 20
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60867-152-02 52 mL in 1 BOTTLE, PUMP None
2 NDC:60867-152-07 200 mL in 1 BOTTLE None
3 NDC:60867-152-18 500 mL in 1 BOTTLE, PUMP None
4 NDC:60867-152-32 1000 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/12/2021
Labeler — Safehands Distribution Ne, LLC (080026877)
Registrant — Safehands Distribution Ne, LLC (080026877)

Revised: 06/2023 Safehands Distribution Ne, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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