Label: AQUAGEL ADVANCED FORMULA- hand sanitizer gel
-
NDC Code(s):
79996-300-01,
79996-300-02,
79996-300-03,
79996-300-04, view more79996-300-05, 79996-300-06, 79996-300-07, 79996-300-08, 79996-300-09, 79996-300-10, 79996-300-11, 79996-300-12, 79996-300-13, 79996-300-14, 79996-300-15, 79996-300-16, 79996-300-17, 79996-300-18, 79996-300-19, 79996-300-20, 79996-300-21, 79996-300-22
- Packager: EPOXEMEX, S.A DE C.V.
- 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 May 4, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Aloe Barbadensis Leaf Extract
- Carbomer
- Fragance
- Glycerin
- Triethanolamine
- 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
-
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
100 mL NDC: 79996-300-22
60 mL NDC: 79996-300-15
120 ml NDC: 79996-300-16
250mL NDC: 79996-300-17
500 mL NDC: 79996-300-18
1 L NDC: 79996-300-19
4000 mL NDC: 79996-300-20
20L NDC: 79996-300-21
946.3 L NDC: 79996-300-14
189.92 L NDC: 79996-300-13
113.5 L NDC: 79996-300-12
20 L NDC: 79996-300-11
500 mL NDC: 79996-300-10
300 mL NDC: 79996-300-09
250 mL NDC: 79996-300-08
120 mL NDC: 79996-300-07
100 mL NDC: 79996-300-06
60 mL NDC: 79996-300-05
4000 mL NDC: 79996-300-04
1000 mL NDC: 79996-300-03
107 mL NDC: 79996-300-02
52 mL NDC: 79996-300-01
-
INGREDIENTS AND APPEARANCE
AQUAGEL ADVANCED FORMULA
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79996-300 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79996-300-04 4000 mL in 1 TANK; Type 0: Not a Combination Product 03/30/2020 12/31/2021 2 NDC:79996-300-01 52 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 3 NDC:79996-300-02 170 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 4 NDC:79996-300-03 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 5 NDC:79996-300-05 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 6 NDC:79996-300-06 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 7 NDC:79996-300-07 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 8 NDC:79996-300-08 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 9 NDC:79996-300-09 300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 10 NDC:79996-300-10 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 12/31/2021 11 NDC:79996-300-11 20000 mL in 1 TANK; Type 0: Not a Combination Product 03/30/2020 12/31/2021 12 NDC:79996-300-12 113500 mL in 1 TANK; Type 0: Not a Combination Product 03/30/2020 12/31/2021 13 NDC:79996-300-13 189920 mL in 1 TANK; Type 0: Not a Combination Product 03/30/2020 12/31/2021 14 NDC:79996-300-14 946300 mL in 1 TANK; Type 0: Not a Combination Product 03/30/2020 12/31/2021 15 NDC:79996-300-15 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2021 16 NDC:79996-300-16 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 17 NDC:79996-300-17 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2021 18 NDC:79996-300-18 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2021 19 NDC:79996-300-19 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/30/2021 20 NDC:79996-300-20 4000 mL in 1 TANK; Type 0: Not a Combination Product 12/30/2021 21 NDC:79996-300-21 20000 mL in 1 TANK; Type 0: Not a Combination Product 12/30/2021 22 NDC:79996-300-22 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - EPOXEMEX, S.A DE C.V. (814573127) Registrant - AY CONSULTING SERVICES, LLC (078311971) Establishment Name Address ID/FEI Business Operations EPOXEMEX, S.A. DE C.V. 814573127 manufacture(79996-300)