P.O.V. Aloe Vera Hand Sanitizer: Package Insert and Label Information

P.O.V. ALOE VERA HAND SANITIZER- alcohol gel
Apollo Health and Beauty Care 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 ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin.

Warnings

For external use only

  • flammable
  • keep away from source of heat or fire

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritaiton or redness develops and lasts.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • put enough product in your palm to cover hands and rub hands together until dry.
  • children under 6 years should be supervised when using this product.

Other information

  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Fragrance (Parfum), Carbomber, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Questions or comments?

1-866-695-3030

Label Copy

Image of the label
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P.O.V. ALOE VERA HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-507
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 650 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER 934
GLYCERIN
ISOPROPYL MYRISTATE
ISOPROPYL ALCOHOL
AMINOMETHYLPROPANOL
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE, DL-
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63148-507-08 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/08/2018
Labeler — Apollo Health and Beauty Care Inc. (201901209)
Registrant — Apollo Health and Beauty Care Inc. (201901209)
Establishment
Name Address ID/FEI Operations
Apollo Health and Beauty Care Inc. 201901209 manufacture (63148-507)

Revised: 10/2018 Apollo Health and Beauty Care Inc.

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