CAL-SHINE ANTISEPTIC HAND SANITIZER- isopropyl alcohol liquid

CAL-SHINE ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

CAL-SHINE ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by California Shine Construction. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product  do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

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

Directions

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

aloe vera leaf extract, glycerin, hydrogen peroxide, lavender oil, water

Questions? +1-559-412-7402

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 4:00 PM

SPL UNCLASSIFIED SECTION

With Lavender Essential Oils and Aloe vera

Manufactured by:
California Shine Construction & Sanitizing,
3251 N Marks Ave, Fresno, CA 93722

​MADE IN THE U.S.A.

Packaging

INGREDIENTS AND APPEARANCE

CAL-SHINE ANTISEPTIC HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78604-646
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78604-646-60	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
2	NDC: 78604-646-11	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
3	NDC: 78604-646-23	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
4	NDC: 78604-646-47	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020
5	NDC: 78604-646-37	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020

Labeler - California Shine Construction (030762135)

Establishment
Name	Address	ID/FEI	Business Operations
California Shine Construction		030762135	manufacture(78604-646)