BIO SPECTRA by BIO SPECTRA / Les Entreprises Stefmar Inc. BIO SPECTRA ATTITUDE®

BIO SPECTRA by

Drug Labeling and Warnings

BIO SPECTRA by is a Otc medication manufactured, distributed, or labeled by BIO SPECTRA, Les Entreprises Stefmar Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIO SPECTRA  ATTITUDE- alcohol solution 
BIO SPECTRA

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.

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BIO SPECTRA ATTITUDE®

Drug Facts

Active ingredient

Ethyl alcohol (72% w/w)

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

• When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

• Stop use and consult a health care professional if irritation or redness develops and persists for more than 72 hours.

• Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

• Flammability warning Keep away from open flame and sources of heat.

Directions

• Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children under 6 when they use this product.

Other information

• Store between 15-30 °C (59-86 F).
• Avoid freezing and excessive heat above 40 °C (104 F).

Inactive ingredients

Water, glycerin, vaccinium angustifolium (blueberry) leaf extract, triethyl citrate, gamma-undecalactone, hexyl acetate, vanillin.

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

ATTITUDE®
bio spectra

little
leaves™
science

hand sanitizer
VANILLA & PEAR
KILLS HARMFUL BACTERIA AND GERMS

EWG VERIFIED
FOR YOUR HEALTH EWG.ORG

100 mL ℮ 3.38 FL. OZ.

BIO SPECTRA   ATTITUDE
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1)
Triethyl citrate (UNII: 8Z96QXD6UM)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
Hexyl acetate (UNII: 7U7KU3MWT0)
Vanillin (UNII: CHI530446X)

Product Characteristics
Color	WHITE (Transluscent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61649-315-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/15/2020
2	NDC: 61649-315-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	11/15/2020

Labeler - BIO SPECTRA (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
Les Entreprises Stefmar Inc.		240496385	MANUFACTURE(61649-315)

Revised: 11/2020

Document Id: 9ffd801c-097a-417e-b04a-28154d1c824b

34390-5

Set id: edef1ecf-eb0d-4162-88b9-cfd3a70174ae

Version: 1

Effective Time: 20201112