OTC Medication Information: I-Softto Instant Hand Sanitizer

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% +/-5% (V/V)

Purpose

Antiseptic

Use

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

Warnings

For external use only.

Flammable ,

Keep product 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

Water, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice.

other information

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

Packaging

image description
(click image for full-size original)

I-SOFTTO INSTANT HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73931-005
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:73931-005-01 500 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 06/23/2020
Labeler — Guangdong Essence Daily Chemical Co., Ltd (529796211)
Establishment
Name Address ID/FEI Operations
Guangdong Essence Daily Chemical Co., Ltd 529796211 manufacture (73931-005)

Revised: 06/2020 Guangdong Essence Daily Chemical Co., Ltd

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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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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