OTC Medication Information: Mad Beauty Hand Sanitizer Marshmallow

MAD BEAUTY HAND SANITIZER MARSHMALLOW- alcohol gel
Mad Beauty USA 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.

DRUG FACTS

Active Ingredient

Ethylalcohol 69%

Purpose

Antimicrobial

Uses

Reduces bacteria on hands.

Warnings

Flammable. Keep away from source of ignition or flame.

For external use only.

Do not use

on open skin wound.

When using this product

keep out of eyes.

Stop use and ask a doctor

if irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a doctor immediately.

Directions

Place pea sized drop onto hands.

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

Water(Aqua)/Eau, Propylene Glycol, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylene Glycol, Fragrance(Parfum), Sodium Hydroxide, Aloe Barbadensis (Aloe Vera) Leaf Extract.

Questions or Comments

MAD BEAUTY USA LLC 1030 SALEM ROAD
UNION NJ 07083 MARYLAND
TEL (844) 995 1701

Package Labeling:

Label11
(click image for full-size original)

MAD BEAUTY HAND SANITIZER MARSHMALLOW
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78789-037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.69 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
GLYCERIN
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
BUTYLENE GLYCOL
SODIUM HYDROXIDE
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78789-037-01 30 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 07/20/2020
Labeler — Mad Beauty USA LLC (117508758)

Revised: 08/2020 Mad Beauty USA 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.

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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