OTC Medication Information: MyRemede Hand Sanitizer

MYREMEDE HAND SANITIZER- alcohol gel
Remede Organics, Inc.

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 ingredients[s]

Alcohol 75% v/v

Purpose

Antiseptic

Uses[s]

Hand sanitizer to help reduse bacteria that potentially can cause disease. For use when stop and water are not available.

warnings

For external use only. Flammable.

Keep away from heat or flame.

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 consult a doctor

if irritation or rash occurs. 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 dyr.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

aqua (water), glycerin, carbomer, propylene glycol, sodium hydroxide, parfum (fragrance), aloe barbadensis leaf extract

Package Labeling 100 ml

Lable
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Package Labeling 280ml

Lable2

Lable2
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Package Labeling 500ml

Lable3
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Package Labeling 2000ml

Lable4
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MYREMEDE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77529-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.75 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
PROPYLENE GLYCOL
SODIUM HYDROXIDE
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77529-000-03 100 mL in 1 BOTTLE None
2 NDC:77529-000-09 280 mL in 1 BOTTLE None
3 NDC:77529-000-16 500 mL in 1 BOTTLE None
4 NDC:77529-000-67 2000 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 05/05/2020
Labeler — Remede Organics, Inc. (117506657)

Revised: 05/2020 Remede Organics, Inc.

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.

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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