Assured Instant Hand Sanitizer Lemon 2 Pk: Package Insert and Label Information

ASSURED INSTANT HAND SANITIZER LEMON 2 PK- alcohol gel
Greenbrier International

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

Ethyl Alcohol 70.0%

Antimicrobial

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • supervise children under 6 years in the use of this product

Use:

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings:

For external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Inactive Ingredients: water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, tocopheryl acetate (Vitamin E), fd&c yellow no. 5.

box
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label
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ASSURED INSTANT HAND SANITIZER LEMON 2 PK
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-3032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5
TROLAMINE
GLYCERIN
PROPYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
WATER
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33992-3032-2 2 BOTTLE in 1 BOX contains a BOTTLE (33992-3032-1)
1 NDC:33992-3032-1 59.2 mL in 1 BOTTLE This package is contained within the BOX (33992-3032-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/21/2017
Labeler — Greenbrier International (610322518)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture (33992-3032)

Revised: 11/2018 Greenbrier International

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