HAND SANITISER: Package Insert and Label Information

HAND SANITISER- alcohol gel
Jiangxi Iris 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.

Active ingredient[s]

Alcohol 75%

Purpose

Antiseptic

Use[s]

Hand Sanitizer to decrease bacteria on the skin that could cause disease.

Use anywhere,anytime;car, office,handbag,picnics, nappy change, camping, travel.

Warnings

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

Do not use

on 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 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 or contact a Poison Control Center right away.

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 15-30C(59-86F)

Avoid freezing and excessive heat above 40C(104F)

Inactive ingredients

Water(Aqua) , Carbomer,Triethanolamine.

Package Label — Principal Display Panel

118.28 ml label
(click image for full-size original)

HAND SANITISER
hand sanitiser gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74440-008
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
TROLAMINE
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74440-008-01 118.28 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/21/2020
Labeler — Jiangxi Iris Chemical Co.,Ltd (544366795)
Registrant — Jiangxi Iris Chemical Co.,Ltd (544366795)
Establishment
Name Address ID/FEI Operations
Jiangxi Iris Chemical Co.,Ltd 544366795 manufacture (74440-008)

Revised: 05/2020 Jiangxi Iris Chemical Co.,Ltd

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