Paw Patrol Fresh Scented Hand Sanitizer: Package Insert and Label Information

PAW PATROL FRESH SCENTED HAND SANITIZER- alcohol gel
Ouya Cosmetics Co., Ltd of Yiwu City

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.

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Active Ingredient

Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire and flames.

Do not use

  • In children less than 2 months of age
  • On open skin wounds

When using this product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

Irritation and redness develop. These may be signs of a serious condition.

Keep out of reach of children

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

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate.

Package Label — Principal Display Panel

Label
(click image for full-size original)

PAW PATROL FRESH SCENTED HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54699-013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
AMINOMETHYLPROPANOL
ALOE VERA LEAF
GLYCERIN
CARBOXYPOLYMETHYLENE
WATER
ALPHA-TOCOPHEROL ACETATE
DENATONIUM BENZOATE
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54699-013-01 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/09/2021
Labeler — Ouya Cosmetics Co., Ltd of Yiwu City (546464926)

Revised: 06/2021 Ouya Cosmetics Co., Ltd of Yiwu City

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