EHS7000: Package Insert and Label Information

EHS7000- alcohol gel
EPIC Chemistry LLC

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.

Active Ingredient

Ethyl Alcohol 70.05 v/v% Antimicrobial

Uses

Help reduce bacteria on the skin

Warnings

For external use only

Flammable. Keep away from heat or flame.

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water. Avoid contact with broken skin. Do not ingest or inhale.

Stop use and ask doctor if skin irritation or redness occurs.

Keep out of reach of children. If swallowed, seek medical attention or contact Poison Control Center immediately.

Directions

Place a generous amount of product on hands and rub hands together until dry.

Other information

Do not store above 100° F. May cause fabric discoloration.

Inactive ingredients

Water (Agua), Sorbitol, Methycellulose, Polyquaternium-10, Fragrance, Glycerin

Dosage

Use a liberal amount in palm of hand.

Notice

Keep out of reach of children.

Indications & Usage

For use when soap and water are not available, or in addition to.

Label

Label
(click image for full-size original)

EHS7000
ehs7000 gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77022-1113
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70.05
Inactive Ingredients
Ingredient Name Strength
WATER 33.12
METHYLCELLULOSE, UNSPECIFIED 0.6
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) 0.6
SORBITOL 1.13
GLYCERIN 0.38
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77022-1113-8 1 GEL in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/17/2020
Labeler — EPIC Chemistry LLC (106734930)
Registrant — Epic Chemistry LLC (106734930)
Establishment
Name Address ID/FEI Operations
EPIC Chemistry LLC 106734930 manufacture (77022-1113)

Revised: 09/2020 EPIC Chemistry LLC

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