FDA Label for Olika Hand Sanitizer Fragrance Free
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT(S)
- PURPOSE
- WARNINGS
- DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- USE
- DIRECTIONS
- 76751-211-01 PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
- 76751-211-02 PACKAGE LABEL _PRINCIPAL DISPLAY PANEL
- 76751-211-03 PACKAGE LABEL_ PRINCIPAL DISPLAY PANEL
Olika Hand Sanitizer Fragrance Free Product Label
The following document was submitted to the FDA by the labeler of this product Perkin And Perkin Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This is a hand sanitizer manufactured according to the 1994 tentative final monograph for hand sanitizers and antiseptics.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) or Food Chemical Codex (FCC) grade ingredients in the preparation of the product. Final formulation finished product testing was performed to confirm efficacy.
- Alcohol (ethanol) (USP) (65%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (4.2% v/v).
- Aloe Babadensis Leaf Extract (0.25% v/v).
- Sterile distilled water or boiled cold water.
Final formulation finished product testing was performed to confirm efficacy.
The formulation comes in 3 package sizes 20 mL, 30 mL, and 90 mL.
On information panel: NDC Code
Active Ingredient(S)
65% Ethyl Alcohol v/v Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, aloe barbadensis leaf extract, purified water USP
Use
Hand Sanitizer to help reduce bacteria on skin.
Directions
Remove nozzle bead. Spray liquid into hands and rub until dry. Use as often as needed.
76751-211-01 Package Label - Principal Display Panel
30 mL
76751-211-02 Package Label _Principal Display Panel
20 mL
76751-211-03 Package Label_ Principal Display Panel
90 mL
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