Hand Sanitizer Frosted Cranberry: Package Insert and Label Information

HAND SANITIZER FROSTED CRANBERRY- alcohol gel
BASE4 Ventures, 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.

Drug Facts

Active Ingredients

Alcohol Denat 66%

Purpose

Antimicrobial

Uses

  • hand sanitizer to help decrease bacteria on the skin.
  • recommended for repeated use.

Warnings

  • For external use only.
  • Flammable.
  • Keep away from heat and flame.
  • Does not contain grain alcohol; do not drink. If taken internally will produce severe gastric disturbances

When using this product,

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if redness or irritation develop and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

Directions

  • Rub dime sized amount between hands until dry
  • Supervise children in the use of this product
  • In the case of eye contact rinse eyes thoroughly with water

Other information

  • Do not store above 105ºF.
  • may discolor some fabrics.

Inactive ingredients:

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance. May Contain: FD&C Red No. 4, FD&C Yellow No. 5, FD&C Blue No. 1, FD&C Red No. 33.

Package Labeling:

Label6
(click image for full-size original)

HAND SANITIZER FROSTED CRANBERRY
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62651-036
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.66 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
AMINOMETHYLPROPANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62651-036-01 30 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/15/2020 07/01/2023
Labeler — BASE4 Ventures, Inc (137316126)

Revised: 09/2021 BASE4 Ventures, Inc

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