OTC Medication Information: PALMA HAND SANITIZER

PALMA HAND SANITIZER- alcohol gel
UNITRADE FZE

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 70% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Warnings

Flammable, keep away from fir e/flame
For external use only

Do not use • in children less than 2 months of age • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

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 and allow to dry without wiping • 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, caprylic /capric triglyceride, avocado (Persea gratissima) oil, propylene glycol, glycerin, jojoba (Simmondsia chinensis) seed oil, peg-40 hydrogenated castor oil, polyacrylamide, c13-14 isoparaffin, laureth-7, acrylates / c10-30 alkyl acrylates crosspolymer, niacinamide, sodium hyaluronate, tocopheryl acetate, panthenol, gotu kola (Centella asiatica) root extract, triethanolamine, fragrance.

Questions? 1-516-535-5555

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM — 5:00 PM

MOISTURIZING

WITH AVOCADO OIL, JOJOBA OIL, VITAMIN B3 & B5

PROTECT. HYDRATE. NOURISH.

Distributed by:
Palma De Salus, Inc
320 Country Road, Suite 205
Garden City, NY 11530, U.S.A


Made in U.A.E.
Designed in Los Angeles
palmadesalus.com

Packaging

image description
(click image for full-size original)

PALMA HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81286-101
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
WATER
MEDIUM-CHAIN TRIGLYCERIDES
AVOCADO OIL
PROPYLENE GLYCOL
GLYCERIN
JOJOBA OIL
POLYOXYL 40 HYDROGENATED CASTOR OIL
POLYACRYLAMIDE (1300000 MW)
C13-14 ISOPARAFFIN
LAURETH-7
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
NIACINAMIDE
HYALURONATE SODIUM
.ALPHA.-TOCOPHEROL ACETATE
PANTHENOL
CENTELLA ASIATICA LEAF
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81286-101-10 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 325 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (81286-101-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/26/2021
Labeler — UNITRADE FZE (864268417)

Revised: 07/2021 UNITRADE FZE

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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