Anti Bacterial Hand Sanitizer: Package Insert and Label Information

ANTI BACTERIAL HAND SANITIZER- alcohol gel
Dolgencorp 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.

Active Ingredients:
Ethyl Alcohol 62%

Purpose:
Antiseptic

Warnings: For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

Do not use in ears or mouth.

When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. Children must be supervised in use of this product.

Directions:
Pump as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Inactive ingredients: Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadenis Leaf Juice

Other information: Do not store in temperature over 118 F.

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use.

image of bottle label
(click image for full-size original)

ANTI BACTERIAL HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-988
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
GLYCERIN
PROPYLENE GLYCOL
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-988-47 29 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 02/22/2016
Labeler — Dolgencorp Inc. (068331990)

Revised: 02/2016 Dolgencorp Inc.

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