Label: FOH HEALTH ESSENTIALS SANITIZER GEL- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79963-100-02, 79963-100-28 - Packager: FOH INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated August 25, 2020
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Packaging
Warnings
For external use only: hands.
FLAMMABLE, KEEP AWAY FROM FIRE OR 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 and
redness develop or condition persists for more than 72 hoursKeep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right
awayInactive Ingredients
Deionized Water, Aloe Vera Gel (Aloe Barbadensis Leaf Juice), Carbomer,
Triethanolamine, Vitamin E (Tocopheryl Acetate).Directions
Wet hands thoroughly 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 105°F ▪ May discolor some fabrics ▪ Harmful to wood finishes and plastics.
70% ALCOHOL
Kills 99.99% of Germs
Aloe Vera & Vitamin E
Fragrance Free*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.
Distributed by: FOH Inc Miami, FL 33138
fohhealth.comCRUELTY FREE
VEGAN
PARABEN FREE
NO SULFATES
MADE IN USA -
INGREDIENTS AND APPEARANCE
FOH HEALTH ESSENTIALS SANITIZER GEL
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79963-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79963-100-02 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2020 2 NDC:79963-100-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/25/2020 Labeler - FOH INC (036479023) Establishment Name Address ID/FEI Business Operations Prive International Inc 058849652 manufacture(79963-100)