I-Softto Instant Hand Sanitizer: Package Insert and Label Information

I-SOFTTO INSTANT HAND SANITIZER- alcohol gel
Guangdong Essence Daily Chemical 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.

Drug Facts

Active ingredient

Ethyl Alcohol 75% (V/V)

Purpose

Antiseptic

Use

  • To help reduce bacteria on the skin
  • recomended for repeated use.

Warnings

For external use only.

Flammable ,

Keep away from fire or flame or sparks.

When using this product

do not use in or neay eyes, In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash appears on the skin.

Keep out of reach of children.

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

Directions

  • Place enough to cover both hands in the palm, and rub hands together until dry
  • Children under 6 years of age should be supervised bu an adult when appling this products.

Inactive ingredients

aloe barbadensis leaf juice, carbomer, Glycerin, Triethanolamine, water

Other information

  • Do not store above 105 Fahrenheit.
  • May discolor certain fabrics or surfaces.
  • Harmful to wood finishes and plastics.

Packaging

image description

I-SOFTTO INSTANT HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73931-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
TROLAMINe
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73931-001-01 100 mL in 1 BOTTLE None
2 NDC:73931-001-02 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 07/30/2019
Labeler — Guangdong Essence Daily Chemical Co., Ltd (529796211)
Registrant — Guangdong Essence Daily Chemical Co., Ltd (529796211)
Establishment
Name Address ID/FEI Operations
Guangdong Essence Daily Chemical Co., Ltd 529796211 manufacture (73931-001)

Revised: 04/2020 Guangdong Essence Daily Chemical Co., Ltd

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