OTC Medication Information: U Alcohol

U ALCOHOL- alcohol gel
Honest Co., Ltd.

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

INACTIVE INGREDIENTS

Water, Aloe Barbadensis Leaf Extract, Glycerin, Carbomer, Butylene Glycol, Citrus Limon Fruit Extract, Triethanolamine, 1,2-Hexanediol

PURPOSE

ANTISEPTIC

WARNINGS

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

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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Hand sanitizer to help reduce bacteria on the skin

Directions

• Place enough product in your palm to cover hands. Rub hands together until dry.

• Children under 6 years of age should be supervised when using the product

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle
(click image for full-size original)

U ALCOHOL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76904-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 350 mL in 500 mL
Inactive Ingredients
Ingredient Name Strength
Water
ALOE VERA LEAF
Glycerin
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Butylene Glycol
LEMON
TROLAMINE
1,2-Hexanediol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76904-100-01 500 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 05/01/2020
Labeler — Honest Co., Ltd. (694773213)
Registrant — Honest Co., Ltd. (694773213)
Establishment
Name Address ID/FEI Operations
Honest Co., Ltd. 694773213 manufacture (76904-100)

Revised: 05/2020 Honest Co., Ltd.

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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