OTC Medication Information: SafeHands

SAFEHANDS- 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 hand sanitizer

Uses

To decrease bacteria on the skin.

Warnings

For external use only.

Do not use

in eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if skin irritation develops.

Keep out of reach of children

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

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, FD&C Blue No. 1

Questions/Comments?

Call toll free 888-338-1338

safeHands®
Next Generation Hand Sanitizer
Kills 99.9% of germs while pampering your hands
Learn more at: www.safehands.com

A percentage of profits is donated to Safe Kids Worldwide
to “keep all kids safe from preventable injuries”

#1 Alcohol Free Brand

Manufactured for safeHands, LLC, Boca Raton, FL
Patent Pending 61/473 385
Made in the USA

safeHands®
Alcohol Free
Hand Sanitizer
Kills 99.9% of germs.
• Non-toxic
• Moisturizing
Clean Linen

20140927 Safehands 102
(click image for full-size original)
SAFEHANDS
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60867-102
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
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60867-102-02 52 mL in 1 BOTTLE None
2 NDC:60867-102-07 208 mL in 1 BOTTLE None
3 NDC:60867-102-18 532 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/01/2023
Labeler — safeHands Distribution Ne, LLC (080026877)
Establishment
Name Address ID/FEI Operations
Vintage Chemical Inc 116949970 manufacture (60867-102)

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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