Not Have: Package Insert and Label Information

NOT HAVE- 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

Alcohol 75% v/v

​Purpose

Use

anywhere,anytime:car,office, handbag,picnics, nappy change,camping, travel,sports etc.

Warnings

KEEP OUT OF REACH OF CHILDREN

Keep out of contact with eyes.If this does occur,flush with water.If skin irritation occurs

seek medical advice.Do not swallow.For external use only.Highly flammable.

DIRECTIONS

Place a small amount of gel in your palm and rub hands together until dry.

Other information

Inactive ingredients

Water(Aqua),Carbomer,Triethanolamine.

Package Label — Principal Display Panel

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

NOT HAVE
hand sanitiser gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74440-004
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
TROLAMINE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74440-004-01 118.28 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/07/2020
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 (74440-004)

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

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