Label requirements · United States

United States label requirements — check your label

What a label sold in United States must carry for food and drinks (fda), cosmetics (fda, mocra), other consumer goods (fpla), medical devices, item by item, each with the law it comes from. Paste your label below: Drict shows what it found, on which line, and what is missing.

Your points to check appear here.

Food and drinks (FDA) — what a United States label must show

4 mandatory · 4 only if it applies

Mandatory

  • Net quantity in both US and metric units: “Net Wt 12 oz (340 g)”, “16 fl oz (473 mL)” (FPLA · 21 CFR 101.105)
  • Ingredients in descending order of weight (21 CFR 101.4; cosmetics: INCI names, 21 CFR 701.3)
  • Name and place of business of the manufacturer, packer or distributor — city, state, ZIP code (“Manufactured for / Distributed by …”, 21 CFR 101.5)
  • Nutrition Facts panel (21 CFR 101.9)

Only if it applies

  • Milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soy or sesame: a “Contains: …” statement right after the ingredients (FALCPA, FASTER Act 2021)
  • Imported goods: country of origin in English, “Product of … / Made in …” (19 CFR 134)
  • California Prop 65: “⚠ WARNING” with www.P65Warnings.ca.gov, if the product exposes consumers to a listed chemical — state law, Cal. Health & Safety Code §25249.6, 27 CCR §25601–25603
  • Deposit refund value on beverage containers sold in CA, CT, HI, IA, ME, MA, MI, NY, OR or VT (“CA CRV”, “MI 10¢”) — state bottle bills

Language: No English found — goods sold in the US are labelled in English (21 CFR 101.15(c)).

Check by eye: Statement of identity: check it yourself — in English, the product's common name in bold on the principal display panel, parallel to the base (21 CFR 101.3). Net quantity in the bottom 30% of the panel, its type size set by the panel's area (21 CFR 101.105(h)).

Check label · Food and drinks (FDA) →

Cosmetics (FDA, MoCRA) — what a United States label must show

4 mandatory · 4 only if it applies

Mandatory

  • Net quantity in both US and metric units: “Net Wt 12 oz (340 g)”, “16 fl oz (473 mL)” (FPLA · 21 CFR 101.105)
  • Ingredients in descending order of weight (21 CFR 101.4; cosmetics: INCI names, 21 CFR 701.3)
  • Name and place of business of the manufacturer, packer or distributor — city, state, ZIP code (“Manufactured for / Distributed by …”, 21 CFR 101.5)
  • A US address, phone number or website for adverse-event reports (MoCRA 2022, since 29 Dec 2024)

Only if it applies

  • Warning where needed (Warning / Caution — 21 CFR 740 for cosmetics)
  • Directions
  • Imported goods: country of origin in English, “Product of … / Made in …” (19 CFR 134)
  • California Prop 65: “⚠ WARNING” with www.P65Warnings.ca.gov, if the product exposes consumers to a listed chemical — state law, Cal. Health & Safety Code §25249.6, 27 CCR §25601–25603

Language: No English found — goods sold in the US are labelled in English (21 CFR 101.15(c)).

Check by eye: Statement of identity: check it yourself — in English, the product's common name in bold on the principal display panel, parallel to the base (21 CFR 101.3). Net quantity in the bottom 30% of the panel, its type size set by the panel's area (21 CFR 101.105(h)).

Check label · Cosmetics (FDA, MoCRA) →

Other consumer goods (FPLA) — what a United States label must show

2 mandatory · 4 only if it applies

Mandatory

  • Net quantity in both US and metric units: “Net Wt 12 oz (340 g)”, “16 fl oz (473 mL)” (FPLA · 21 CFR 101.105)
  • Name and place of business of the manufacturer, packer or distributor — city, state, ZIP code (“Manufactured for / Distributed by …”, 21 CFR 101.5)

Only if it applies

  • Imported goods: country of origin in English, “Product of … / Made in …” (19 CFR 134)
  • Directions
  • Warning where needed (Warning / Caution — 21 CFR 740 for cosmetics)
  • California Prop 65: “⚠ WARNING” with www.P65Warnings.ca.gov, if the product exposes consumers to a listed chemical — state law, Cal. Health & Safety Code §25249.6, 27 CCR §25601–25603

Language: No English found — goods sold in the US are labelled in English (21 CFR 101.15(c)).

Check by eye: Statement of identity: check it yourself — in English, the product's common name in bold on the principal display panel, parallel to the base (21 CFR 101.3). Net quantity in the bottom 30% of the panel, its type size set by the panel's area (21 CFR 101.105(h)).

Check label · Other consumer goods (FPLA) →

Medical devices — what a United States label must show

3 mandatory · 5 only if it applies

Mandatory

  • Name and place of business of the manufacturer, packer or distributor — 21 CFR 801.1
  • Adequate directions for use, or where to find them — 21 CFR 801.5
  • Unique Device Identifier (UDI), plain text and AIDC — 21 CFR 801.20

Only if it applies

  • Prescription device: “Rx only” or “Caution: Federal law restricts this device to sale by or on the order of a …” — 21 CFR 801.109
  • Net quantity of contents, for an over-the-counter device — 21 CFR 801.61, 801.62
  • Warnings and cautions — 21 CFR 801.5(a)
  • “This product contains natural rubber latex which may cause allergic reactions”, if it does — 21 CFR 801.437
  • California Prop 65: “⚠ WARNING” with www.P65Warnings.ca.gov, if the product exposes consumers to a listed chemical — state law, Cal. Health & Safety Code §25249.6, 27 CCR §25601–25603

Language: No English found — device labels sold in the United States are in English (21 CFR 801.15(c)).

Check by eye: The device’s common name on the principal display panel (OTC, 801.61); the UDI’s barcode and its date format (801.18, YYYY-MM-DD); stand-alone symbols are allowed only from a recognised standard such as ISO 15223-1 with a symbols glossary in the labeling (801.15(c)) — Drict reads only words.

Check label · Medical devices →

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