OTC Medication Information: FRESH CITRUS HAND SANITIZER

FRESH CITRUS HAND SANITIZER- alcohol liquid
Absara Cosmetics S.A.P.I DE C.V.

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

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not ingest, if swallowed seek medical help.

Avoid contact with eyes.

Keep out of reach of children. Children under 10 years old to use under adult supervision. In case of irritation, discontinue use and consult your doctor.

Directions

Apply the gel on the hands and rub gently for 25 seconds until the product evaporates.

Other information

Store below 106° F (41°C), May discolor certain fabrics or surfaces.

Inactive ingredients

Demineralized water, glycerin, carbomer, Fragrance, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.

Distributed by: Cross Border Manufacturers Inc, 8 The Green Ste #10166 Dover, DE 19901

PRINCIPAL DISPLAY PANEL — 250 ml Bottle Label

aglamee®

FRESH CITRUS

HAND
SANITIZER

FORMULATED WITH
70%
OF ALCOHOL

ANTIMICROBIAL ACTION

RINSE
FREE

WITH ALOE VERA & GLYCERINE

8.4 FL OZ (250 ml)

PRINCIPAL DISPLAY PANEL -- 250 ml Bottle Label
(click image for full-size original)
FRESH CITRUS HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70956-011
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
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
DMDM HYDANTOIN
IODOPROPYNYL BUTYLCARBAMATE
BUTYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70956-011-01 250 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 05/25/2020
Labeler — Absara Cosmetics S.A.P.I DE C.V. (816161236)
Establishment
Name Address ID/FEI Operations
Absara Cosmetics S.A.P.I DE C.V. 816161236 MANUFACTURE (70956-011)

Revised: 06/2020 Absara Cosmetics S.A.P.I DE C.V.

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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