E-PU Premium Mandarin Hand Sanitizer 70% 946ml: Package Insert and Label Information

E-PU PREMIUM MANDARIN HAND SANITIZER 70% 946ML- alcohol gel
E.CIS COSMETIC.Co.,Ltd

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)

Alcohol 70% v/v. Purpose: Antiseptic

Active ingredients
(click image for full-size original)

Purpose

Antiseptic, Hand Sanitizer

PurposePurpose

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

UseUse

Warnings

For external use only. Flammable. Keep away from heat or flame

WarningsWarnings

Do not use

  • in children less than 2 months of age
  • on open skin wounds
  • Do not use
Do not use

When using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
When using

Stop use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop useStop use

Keep out

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep outKeep out

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.
  • Directions
Directions

Other information

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

Inactive ingredients

Water, Glycerin, Fragrance, Carbomer, Aminomethyl Propanol, Mentha Arvensis Leaf Oil, Tocopheryl Acetate, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract

inactive ingredientsinactive ingredients

Questions

1-800-819-4159

QuestionsQuestions

Package Label — Principal Display Panel

E-Pu

Premium Mandarin

Hand Sanitizer

70% Ethyl Alcohol as recommended

Help reduce bacteria on the skin

Natural* Mandarin Zest and Herbal Oils Blend

Complies with ISO 9235**

Glycerin, Sodium Hyaluronate

& Aloe Vera to replace Moisture

946ml (32fl.oz.)

PDPPDP
E-PU PREMIUM MANDARIN HAND SANITIZER 70% 946ML
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73862-210
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
MENTHA ARVENSIS LEAF OIL
PANTHENOL
HYALURONATE SODIUM
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
AMINOMETHYLPROPANOL
GLYCERIN
CARBOMER 940
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73862-210-03 2 CARTON in 1 PACKAGE contains a CARTON (73862-210-02)
1 NDC:73862-210-02 36 BOTTLE in 1 CARTON This package is contained within the PACKAGE (73862-210-03) and contains a BOTTLE (73862-210-01)
1 NDC:73862-210-01 946 mL in 1 BOTTLE This package is contained within a CARTON (73862-210-02) and a PACKAGE (73862-210-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — E.CIS COSMETIC.Co.,Ltd (689846270)
Establishment
Name Address ID/FEI Operations
E.CIS COSMETIC.Co.,Ltd 689846270 manufacture (73862-210)

Revised: 06/2020 E.CIS COSMETIC.Co.,Ltd

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