SOLEIL HAND SANITIZER- ethyl alcohol gel

Soleil Hand Sanitizer by

Drug Labeling and Warnings

Soleil Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sutra Beauty Inc, Guangzhou Joy Claire Biological Technology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive ingredients

Aloe Barbadensis Leaf Extract, Aqua, Camellia Sinensis Leaf Oil, Carbomer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Parfum.

Purpose

Antiseptic

Use

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

Warnings

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

Do not use

• On children less than 2 months of age.
• On open skin wounds.

WHEN USING

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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 (1-800-222-1222).

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Questions or Comments?

Call 1-888-463-6332 Monday-Friday 9AM-5PM EST FDA NDC Product Code: 76741-004-12

Package Label - Principal Display Panel

​120 ml NDC: 76741-004-12

INGREDIENTS AND APPEARANCE

SOLEIL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76741-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TEA LEAF OIL (UNII: VC855RRT77)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76741-004-12	120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/19/2020

Labeler - Sutra Beauty Inc (040228928)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Joy Claire Biological Technology Co.,Ltd		418209894	manufacture(76741-004)