Label: SHIELDFORCE AFS- hand sanitizer liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80743-245-02, 80743-245-04, 80743-245-08, 80743-245-17 - Packager: Force Fluids LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 19, 2020
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- 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:
- Benzalklonium Chloride (.11% w/v)
- Glycerin (.64% v/v).
- Fragrance (0.75% 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
SHIELDFORCE AFS
hand sanitizer liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80743-245 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM 1 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80743-245-02 60 mL in 1 BOTTLE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 11/05/2020 2 NDC:80743-245-04 118 mL in 1 BOTTLE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 11/05/2020 3 NDC:80743-245-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/05/2020 4 NDC:80743-245-17 3785.41 mL in 1 BOTTLE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 11/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Multi-Market Approved Product 11/05/2020 Labeler - Force Fluids LLC (099027352) Establishment Name Address ID/FEI Business Operations Force Fluids LLC 099027352 manufacture(80743-245)