Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 78614-435
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hidden Springs Manufacturing Llc. for the product Hand Sanitizer (NDC 78614-435). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- on children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
water, glycerin, carbomer, propylene glycol, squalane, fragrance, aloe barbadensis leaf juice, tocopheryl acetate
Package Label - Principal Display Panel
010 mL NDC: 78614-435-10
10ml Label (Pk L Fh10mlg Curves Rev200619 01)
030 mL NDC: 78614-435-30
30 mL Label (Rw 901 T Fh Curves Rev200624 01)
050 mL NDC: 78614-435-50
050 mL Ndc: 78614-435-50 (Pk L Hsang50mlc Curves Rev200624 01)
050 mL Ndc: 78614-435-50 (Pk L Hsang50mlc Curves Rev200624 02)
118 mL NDC: 78614-435-04
118 mL Ndc: 78614-435-04 (Pk L Fh4g Curves Rev200615 01)
473 mL NDC: 78614-435-16
473 mL Label (Pk L Hsang16 2 Curves Rev200619 01)
473 mL Ndc: 78614-435-16 (Pk L Hsang16 1 Curves Rev200619 01)
1892 mL NDC: 78614-435-64
1892 mL Ndc: 78614-435-64 (Pk L Fh64g Curves Rev200616 01)
236 mL NDC: 78614-435-08
8oz Label (Pk L Hsang8 Curves Rev200619 02)
236 mL Ndc: 78614-435-08 (Pk L Hsang8 Curves Rev200619 01)
3785 mL NDC: 78614-435-28
3785 mL Ndc: 78614-435-28 (Pk L Fh128g Curves Rev200616 01)
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