KEEP US SAFE HAND SANITIZER: Package Insert and Label Information

KEEP US SAFE HAND SANITIZER- alcohol gel
Ivy Rose 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 ingredient

Alcohol 75% v/v

Purpose

Antiseptic

Uses

  • 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 heat or flame.

When using this product

  • keep out of eyes, ears, ans mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask 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 right away.

Do not use

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

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

Carbomer, glycerin, sterile distilled water, triethanolamine.

Package Labeling:50ml

Bottle
(click image for full-size original)

Package Labeling:500ml

Bottle2
(click image for full-size original)

KEEP US SAFE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79247-000
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
WATER
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79247-000-00 50 mL in 1 BOTTLE None
2 NDC:79247-000-01 500 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 07/15/2020
Labeler — Ivy Rose Inc (037401255)
Establishment
Name Address ID/FEI Operations
Guangdong Kang Rong Industrial Co.,Ltd 560529816 manufacture (79247-000)

Revised: 07/2020 Ivy Rose Inc

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