B Free Hand Sanitizer with Aloe Vera and Vitamin E: Package Insert and Label Information

B FREE HAND SANITIZER WITH ALOE VERA AND VITAMIN E- alcohol liquid
b+free

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 ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

  • hand sanitizer to decrease bacteria on the skin.
  • recommended for repeated use
  • for use when soap and water are not available.

Warnings

Flammable, keep away from fire/flame. For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product

  • do not get into eyes. In case of contact, rinse eyes thoroughly with water
  • do not inhale or ingest.

Stop and ask doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

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 and allow to dry without wiping.
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

  • store between 15-30ºC (59-86ºF)
  • avoid freezing and excessive heat above 40ºC (104ºF)
  • may discolor certain fabrics or surfaces

Inactive ingredients

Water, Glycerin, Fragrance, Tocopheryl Acetate (VITAMIN E), Aloe Barbadensis Leaf Extract.

Package Labeling:1000ml

Label4
(click image for full-size original)

Package Labeling — 1 Gallon

1 gallon
(click image for full-size original)

B FREE HAND SANITIZER WITH ALOE VERA AND VITAMIN E
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:90120-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:90120-001-01 1000 mL in 1 BOTTLE None
2 NDC:90120-001-02 3790 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 09/01/2020 07/01/2023
Labeler — b+free (013549109)

Revised: 09/2022 b+free

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