OTC Medication Information: O Plus Instant Hand Sanitizer

O PLUS INSTANT HAND SANITIZER- alcohol gel
Opal Cosmetics (Huizhou) Limited

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

Ethyl alcohol 75%

Purpose

Antiseptic

Use

For hand washing to decrease bacetria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use

in the eyes

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 allow to dry without wiping

Other information

  • do not store above 105°F.
  • may discolor certain fabrics
  • harmful to wood finishes and plastics

Inactive ingredients

Water, glycerin, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, aminomethyl propanol, aloe vera leaf extract, denatonium benzoate, t-butyl alcohol, maltodextrin.

​Package Labeling: 42477-4408-3

95mL

Package Labeling: 42477-4408-2

500mL

O PLUS INSTANT HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42477-4408
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.75 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
AMINOMETHYLPROPANOL
ALOE VERA LEAF
DENATONIUM BENZOATE
TERT-BUTYL ALCOHOL
MALTODEXTRIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42477-4408-3 95 mL in 1 BOTTLE None
2 NDC:42477-4408-2 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/06/2020
Labeler — Opal Cosmetics (Huizhou) Limited (528178475)

Revised: 04/2020 Opal Cosmetics (Huizhou) Limited

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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