OTC Medication Information: HAND SANITIZER 70 ALCOHOL

HAND SANITIZER 70 ALCOHOL- alcohol gel
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 Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin when water and soap are not available.

Warnings

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

When using this product:

Keep out of eyes. In case of contact with eyes, rinse thoroughly with water.

Do not use on broken or irritated skin.

Stop use and ask a doctor if

irritation or redness develop and last more than 3 days.

Keep out of the reach of children.

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

Directions

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other Information

  • Do not store above 105 F° (40°C)
  • May discolor some fabrics and wood surfaces.

Inactive Ingredients

Demineralized water, glycerin, carbomer, 1fragrance, triethanolamine, dmdm hydantoin, aloe barbadensis extract, iodopropynyl butylcarbamate, butylene glycol.


1
May contain this ingredient

Questions or comments?

(281) 882-8850

Distributed by Interbrands Group, LLC
331 Corporate Woods Dr, Suite A4,
Magnolia, TX 77354

PRINCIPAL DISPLAY PANEL — 1 GALLON Bottle Label

HAND SANITIZER
GEL

Hygeia
pure

INFUSED WITH
ALOE VERA
& GLYCERIN

1 GALLON (128 FL OZ)

70%
ALCOHOL

PRINCIPAL DISPLAY PANEL -- 1 GALLON Bottle Label
(click image for full-size original)
HAND SANITIZER 70 ALCOHOL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70956-015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
DMDM HYDANTOIN
IODOPROPYNYL BUTYLCARBAMATE
BUTYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70956-015-02 59 mL in 1 TUBE None
2 NDC:70956-015-04 118 mL in 1 TUBE None
3 NDC:70956-015-06 200 mL in 1 TUBE None
4 NDC:70956-015-08 3785.41 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 05/21/2020
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 (70956-015)

Revised: 07/2020 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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