SunDrops 73 by Sunburst Chemicals, Inc.

SunDrops 73 by

Drug Labeling and Warnings

SunDrops 73 by is a Otc medication manufactured, distributed, or labeled by Sunburst Chemicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNDROPS 73- alcohol soap 
Sunburst Chemicals, 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.

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Drug Facts

Active Ingredient

Ethyl Alcohol 65% v/v

Purpose

Skin Sanitizer

Use

To help reduce the amount of bacteria on skin

Warnings

Flammable. Keep away from fire or flame.

For external use only. If swallowed seek medical attention.

When using this product do not use around or near the eyes. If contact occurs, flush eyes with water and contact a doctor immediately.

Stop use and consult a doctor when skin irritation appears and lasts.

KEEP OUT OF REACH OF CHILDREN.

Directions

• Pump a small amount of foam into palm of hand.
• Spread on hands and rub into skin until dry.
• Pump a smaller amount (2.5 grams) into one hand and spread over both hands and wrists.
• Rub into skin until dry.
• Children should be supervised while using this product.

Inactive Ingredients

Water, DEA-C8-18 Perfluoroalkylethyl Phosphate, Glycerin

PRINCIPAL DISPLAY PANEL - Label

SUNBURST CHEMICALS

SunDrops 73

Contains 6 Bottles
Net Contents Each 16 fl. oz. (1 pt.) 500 mL
Total Net Volume 96 fl. oz. (3 qt.) 3 L

SUNDROPS 73 
alcohol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63621-355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	650 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)

Product Characteristics
Color	white (water white - colorless, dispensed as white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63621-355-50	6 in 1 BOX	10/14/2009	03/18/2020
1		0.500 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 63621-355-55	8 in 1 BOX	10/14/2009	03/18/2020
2		1 L in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/14/2009	03/18/2020

Labeler - Sunburst Chemicals, Inc. (006159339)

Revised: 3/2020

Document Id: 7cf24358-8839-4c03-8377-299d5185e65c

34390-5

Set id: a188129a-ab1d-4ddf-a1d0-9a0eb04b60dc

Version: 4

Effective Time: 20200318

 

Sunburst Chemicals, Inc.