OTC Medication Information: Hand Sanitizer Gel

HAND SANITIZER GEL- alcohol gel
Califormulations LLC

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.

Active Ingredient

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame

When using this product

  • Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persist 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 wit product to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product.
  • Not recommended for infants.

Other information

  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor certain fabrics or surfaces

Inactive ingredients

Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Triethanolamine, Frangrance (Parfum)

Package Label — Principal Display Panel

8oz Hand Sanitizer Gel
(click image for full-size original)

237 mL NDC: 74391-003-08

HAND SANITIZER GEL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74391-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TRIETHYLAMINE
ALOE VERA LEAF
WATER
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (4500 MPA.S)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74391-003-08 237 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 08/03/2020
Labeler — Califormulations LLC (945269491)
Establishment
Name Address ID/FEI Operations
Califormulations LLC 945269491 manufacture (74391-003)

Revised: 08/2020 Califormulations LLC

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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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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