OTC Medication Information: Raw Sugar Hand Sanitizer Eucalyptus and Tea Tree

RAW SUGAR HAND SANITIZER EUCALYPTUS AND TEA TREE- alcohol gel
Bolero Home Decor, Inc.

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 62%

Purpose

Antimicrobial

Uses

  • Hand sanitizing to reduce bacteria on the skin that could cause disease
  • Recommended for repeated use

Warnings

Flammable. Keep away from fire or flame.
For external use only. Do not inhale or ingest.

Avoid contact with eyes. In case of eye contact, fush eyes with water.

Stop use and see a doctor if

  • irritation or redness develops
  • 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

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children under the age of 6 should be supervised when using this product

Other Information

  • Store at 20-25°C (68-77°F)
  • May discolor certain fabrics or surfaces.

Inactive Ingredients

Water (Aqua), Carbomer, Aminomethyl Propanol, Glycerin, *Eucalyptus Globulus Leaf Extract, Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract, *Aloe Barbadensis (Aloe Vera) Leaf Juice, Geraniol, Linalool, Limonene, Fragrance (Parfum) *Certified Organic

Package Labeling:59ml

59 mL
(click image for full-size original)

266 mL
(click image for full-size original)

RAW SUGAR HAND SANITIZER EUCALYPTUS AND TEA TREE
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57469-071
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.62 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
AMINOMETHYLPROPANOL
GLYCERIN
EUCALYPTUS GLOBULUS LEAF
MELALEUCA ALTERNIFOLIA FLOWERING TOP
ALOE VERA LEAF
GERANIOL
LINALOOL, (+/-)-
LIMONENE, (+)-
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57469-071-01 59 mL in 1 BOTTLE None
2 NDC:57469-071-02 266 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 10/01/2020 11/01/2022
Labeler — Bolero Home Decor, Inc. (067967365)

Revised: 10/2021 Bolero Home Decor, Inc.

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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