Label: 4 UKLEAN HAND SANITIZER- isopropyl alcohol gel
79038-070-16, view more79038-070-32
- Packager: Creek Pine Group Miami Corp.
- 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.
Updated June 22, 2020
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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:
- Isopropyl Alcohol (75%, 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)
- Do not use
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
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
4 UKLEAN HAND SANITIZER
isopropyl alcohol gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79038-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.0125 mL in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0145 mL in 1 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79038-070-01 3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/30/2020 2 NDC:79038-070-02 59.1471 mL in 1 POUCH; Type 0: Not a Combination Product 03/30/2020 3 NDC:79038-070-16 473.176 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 03/30/2020 4 NDC:79038-070-32 946.353 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 03/30/2020 5 NDC:79038-070-05 18927.1 mL in 1 PAIL; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Creek Pine Group Miami Corp. (117552479) Establishment Name Address ID/FEI Business Operations Creek Pine Group Miami Corp. 117552479 manufacture(79038-070)