Label: AURORA FRESH GEL 71- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77807-005-09 - Packager: Aurora Specialty Chemistries
- 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 March 24, 2021
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a gel hand sanitizer manufactured according to standard cGMP.
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 existing hand sanitizer products sold OTC throughout the United States and Globally:Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin (1.39% v/v).
Hydroxymethyl Cellulose (0.7% v/v).
Isopropyl Myristate (0.07% v/v)
DL-Alpha-Tocopherol Acetate (0.07% v/v)
Sterile distilled water (27.77% v/v).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(s)
- 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 besigns 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
AURORA FRESH GEL 71
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77807-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 L in 1 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 27.77 L in 1 L HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) 0.7 L in 1 L GLYCERIN (UNII: PDC6A3C0OX) 1.39 L in 1 L ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.07 L in 1 L .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.07 L in 1 L Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77807-005-09 0.05 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 03/24/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/24/2021 Labeler - Aurora Specialty Chemistries (108423153) Establishment Name Address ID/FEI Business Operations Aurora Specialty Chemistries 117783355 manufacture(77807-005)
