SUPERNOVA LAB PURE ORANGE- alcohol gel

Supernova Lab Pure Orange by

Drug Labeling and Warnings

Supernova Lab Pure Orange by is a Otc medication manufactured, distributed, or labeled by Supernova Coating, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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)

Inactive ingredients

Carbomer, Distilled Water, Triethanolamine, Aloe Vera and Essential Oils.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SUPERNOVA LAB PURE ORANGE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76726-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76726-002-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
2	NDC: 76726-002-02	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
3	NDC: 76726-002-03	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
4	NDC: 76726-002-04	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
5	NDC: 76726-002-05	20000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
6	NDC: 76726-002-06	1000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020

Labeler - Supernova Coating, S.A. de C.V. (812888601)

Establishment
Name	Address	ID/FEI	Business Operations
Supernova Coating, S.A. de C.V.		812888601	manufacture(76726-002)