OTC Medication Information: CAL-SHINE ANTISEPTIC HAND SANITIZER

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.

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

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
GLYCERIN
HYDROGEN PEROXIDE
LAVENDER OIL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78604-646-60 60 mL in 1 BOTTLE None
2 NDC:78604-646-11 118 mL in 1 BOTTLE None
3 NDC:78604-646-23 237 mL in 1 BOTTLE None
4 NDC:78604-646-47 474 mL in 1 BOTTLE None
5 NDC:78604-646-37 3785 mL in 1 BOTTLE None
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 Operations
California Shine Construction 030762135 manufacture (78604-646)

Revised: 08/2020 California Shine Construction

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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