OTC Medication Information: 3PK Hand Sanitizer

3PK HAND SANITIZER- alcohol solution
Best Brand Consumers Products, 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.

Active Ingredient(s)

Ethyl Alcohol 68%

Purpose

Antiseptic

Use

To decrease the bacteria on the skin that could cause disease

Recommended for repeated use

Warnings

For external use only.

Flammable. Keep away from heat and flame

Discontinue if skin becomes irritated and ask a doctor

Keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not inhale or ingest

Avoid contact with broken skin

Keep out of reach of children. In case of accidental ingestion, seek professional assitance or contact a Poison Control Center immediately.

Directions

Wet hands thoroughly with products and rub untill dry withour wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wooden finishes and plastics

Inactive ingredients

Water, glycerin, propylene glycol, carbomer, sodium hydroxide. May contain: Red 33, Blue 1, Yellow 5

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3PK HAND SANITIZER
alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74530-041
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 68 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
SODIUM HYDROXIDE
WATER
CARBOMER 940
PROPYLENE GLYCOL
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74530-041-01 3 BOTTLE in 1 PACKAGE contains a BOTTLE
1 60 mL in 1 BOTTLE This package is contained within the PACKAGE (74530-041-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/30/2020
Labeler — Best Brand Consumers Products, Inc. (058304494)
Establishment
Name Address ID/FEI Operations
Ningbo Haishu Huayu Industry & Trade Co., Ltd. 527157032 manufacture (74530-041)

Revised: 08/2020 Best Brand Consumers Products, Inc.

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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