Label: EHS7000 gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77022-1113-8 - Packager: EPIC Chemistry LLC
- 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 September 17, 2020
If you are a consumer or patient please visit this version.
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- Active Ingredient
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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.
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- Inactive ingredients
- Dosage
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- Indications & Usage
- Label
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INGREDIENTS AND APPEARANCE
EHS7000
ehs7000 gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77022-1113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70.05 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 33.12 METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) 0.6 POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS) 0.6 SORBITOL (UNII: 506T60A25R) 1.13 GLYCERIN (UNII: PDC6A3C0OX) 0.38 Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77022-1113-8 1 in 1 BOTTLE; Type 0: Not a Combination Product 09/17/2020 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 Business Operations EPIC Chemistry LLC 106734930 manufacture(77022-1113)