HAND SANITIZER- ethyl alcohol gel
CAPNA Fabrication
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.
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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:
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purified Water, Acrylates Copolymer, Glycerin, Aminomethylpropanol, Hydrogen Peroxide
The label image provided below,
pertains to the following packaging sizes and NDC codes:
2 Oz / 59 mL 77434-001-01
4 Oz / 118 mL 77434-001-02
6.4 Oz / 189 mL 77434-001-03
8 Oz / 236 mL 77434-001-04
11.8 Oz / 349 mL 77434-001-05
12.6 Oz / 375 mL 77434-001-06
16 Oz / 473 mL 77434-001-07
1 Gal / 3785 mL 77434-001-11
The label image provided below,
pertains to the following packaging sizes and NDC codes:
2 Oz / 59 mL 77434-002-01
4 Oz / 118 mL 77434-002-02
6.4 Oz / 189 mL 77434-002-03
8 Oz / 236 mL 77434-002-04
11.8 Oz / 349 mL 77434-002-05
12.6 Oz / 375 mL 77434-002-06
16 Oz / 473 mL 77434-002-07
1 Gal / 3785 mL 77434-002-11
HAND SANITIZER
ethyl alcohol gel |
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HAND SANITIZER
ethyl alcohol gel |
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Labeler - CAPNA Fabrication (019040504) |
Registrant - CAPNA Fabrication (019040504) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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CAPNA Fabrication | 019040504 | manufacture(77434-001, 77434-002) |