Label: EDEN HAND SANITIZER- alchohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78662-702-01, 78662-702-02, 78662-702-04, 78662-702-12, view more78662-702-16, 78662-702-50, 78662-702-75 - Packager: Rx SAN LLC
- Category: HUMAN OTC DRUG LABEL
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 January 25, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
EDEN HAND SANITIZER
alchohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78662-702 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 73.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL WATER (UNII: 059QF0KO0R) ECAMSULE DITRIETHANOLAMINE (UNII: 078Q44I6CD) 0.24 mL in 100 mL CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) 1.8 mL in 100 mL .ALPHA.-CITRONELLAL (UNII: A02IC9965Z) 0.3 mL in 100 mL ALOE (UNII: V5VD430YW9) 0.5 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78662-702-01 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2021 2 NDC:78662-702-16 473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/2021 3 NDC:78662-702-12 355 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/2021 4 NDC:78662-702-04 118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/2021 5 NDC:78662-702-75 1041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 01/01/2021 6 NDC:78662-702-50 18927 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/01/2021 7 NDC:78662-702-02 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 01/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2021 Labeler - Rx SAN LLC (117536764) Registrant - Rx SAN LLC (117536764) Establishment Name Address ID/FEI Business Operations Rx SAN 117536764 manufacture(78662-702) Establishment Name Address ID/FEI Business Operations Vitalpure Labs LLC 117797259 manufacture(78662-702)