Safe4U Hand Sanitizer Moisturizing: Package Insert and Label Information

SAFE4U HAND SANITIZER MOISTURIZING- alcohol liquid
Chae Manufacturing, 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.

Drug Facts

Active Ingredient

Ethyl Alcohol 64%

Purpose

Antiseptic

Uses

  • Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using this product

avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

Stop use and ask a doctor if

irritation or redness develops.

Keep out of reach of children.

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

Directions

  • Spray onto hands, wetting thoroughly with product. Rub into skin until dry
  • Children under 6 years of age should be supervised by an adult when using this product.

Inactive Ingredients

Purified Water (Aqua), Aloe Barbadensis Leaf Juice*, Propanediol, Citrus Aurantium Dulcis (Orange) Oil*, Zingiber Officinale Root (Ginger) Oil*, Camellia Sinensis Leaf Extract*. *Organic

​Questions or Comments?

(719)738-2000

shob.gobeyondnatural.com

Package Labeling:

Label
(click image for full-size original)

Package Labeling: 72434-100-04

Label2
(click image for full-size original)

SAFE4U HAND SANITIZER MOISTURIZING
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72434-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.64 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
PROPANEDIOL
ORANGE OIL
GINGER OIL
GREEN TEA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72434-100-01 30 mL in 1 BOTTLE, SPRAY None
2 NDC:72434-100-04 120 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/09/2020
Labeler — Chae Manufacturing, LLC (074439626)

Revised: 04/2020 Chae Manufacturing, LLC

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