CAL-SHINE ANTISEPTIC HAND SANITIZER- isopropyl alcohol liquid 
California Shine Construction

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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CAL-SHINE ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Uses

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

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

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

Directions

Other information

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

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

untitled

CAL-SHINE ANTISEPTIC HAND SANITIZER 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78604-646
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78604-646-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
2NDC:78604-646-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
3NDC:78604-646-23237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
4NDC:78604-646-47474 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
5NDC:78604-646-373785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
Labeler - California Shine Construction (030762135)
Establishment
NameAddressID/FEIBusiness Operations
California Shine Construction030762135manufacture(78604-646)

Revised: 1/2023
Document Id: 3f54e374-3eef-4e66-8d52-aace004432c5
Set id: 45489785-2228-4bf7-83c0-9160e357cffc
Version: 4
Effective Time: 20230112
 
California Shine Construction