Advanced Hand Sanitizer Aloe

Advanced Hand Sanitizer Aloe

Drug Labeling and Warnings

Drug Details

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ADVANCED HAND SANITIZER- alcohol gel 
Harmon Stores, Inc

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.

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Advanced Hand Sanitizer Aloe

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that could cause disease
• recommend for repeated use

Warnings

For external use only-hands

Flammable. Keep away from heat and flame.

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin
• do not inhale or ingest

Stop use and ask a doctor if

• irritation or redness develops
• 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 thoroghly with product and allow to dry without wiping
• for children under 6, use only under adult supervision
• not recommended for infants

Other information

• do not store above 105⁰ F
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

water,  aloe barbadensis leaf juice, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, blue 1, yellow 5

*This product is not manufactured or distributed by GOJO Industries, Inc. distributor of Purell Refreshing Aloe Advanced Hand Sanitizer

**Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds

Distributed by Harmon Stores, Inc
650 Liberty Ave., Union, NJ 07083 UA
Harmon Stores, Inc
Visit us at: www.facevalues.com

Principal Display Panel

FACEVALUES

Compare to Purell

ADVANCED HAND SANITIZER

Kills More than 99.99% of Germs**

Moisturizing Formula with Vitamin E

Leaves Hands Feeling Soft

with aloe

2 FL OZ (59 mL)

439.000/439AB

ADVANCED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	616 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER COPOLYMER TYPE b (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-439-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2014
2	NDC: 63940-439-16	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2014
3	NDC: 63940-439-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/18/2014

Labeler - Harmon Stores, Inc (804085293)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(63940-439)

Revised: 12/2018

Document Id: 45140803-4e16-4b78-9bf3-11054a80c2bc

34390-5

Set id: 651b7bb8-0fc9-4d66-ae77-a6b96e52daf4

Version: 4

Effective Time: 20181226

 

Harmon Stores, Inc