Dramaholic Hand Sanitizer: Package Insert and Label Information

DRAMAHOLIC HAND SANITIZER- alcohol gel
DONG IL PHARMS 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.

Alcohol

water, glycerin, carbomer, triethanolamine

Antiseptic

KEEP OUT OF REACH OF THE CHILDREN

For the external use only

Do not use on the following body parts.
Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)
If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

Symptoms of skin irritation

Other precautions

For external use only
Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.
Be careful not to inhale vapor when using it extensively or for a long time. (If you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur).
When repeated use on the same site, be careful as the skin may become rough due to degreasing.
When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.
Do not use for any other purpose.

Wet hands thoroughly with product and allow to dry without wiping. For children under 6 use only under adult supervision.

Not recommended for infants.

DRAMAHOLIC HAND SANITIZER alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73242-0200 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 42 mL in 60 mL

Inactive Ingredients Ingredient Name Strength TROLAMINE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73242-0200-1 60 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 06/15/2020

Labeler — DONG IL PHARMS CO., LTD. (557810721)

Registrant — DONG IL PHARMS CO., LTD. (557810721)

Establishment
Name	Address	ID/FEI	Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture (73242-0200)

Revised: 06/2020 DONG IL PHARMS CO., LTD.