Poor Cosmetic Ingredient Sensitization Data

Neomycin

INCI: NEOMYCIN SULFATE

CAS Number
1404-04-2 (base); 1405-10-3 (sulfate salt)
Function
Antimicrobial
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Regulated as an OTC drug (antibiotic) by FDA. Any product containing neomycin is classified as a drug, not a cosmetic.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Neomycin based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
other
EU Allergen Listed
no
Patch Test Positive Rate
3.5%
Cross-reactivity Group
aminoglycoside-group
Reaction Type
contact-dermatitis

Source: NACDG

Expert Verdict

Neomycin is a potent contact allergen with cross-reactivity to other aminoglycosides, carries ototoxicity and nephrotoxicity risks with systemic absorption, contributes to antimicrobial resistance, and would trigger regulatory reclassification of any cosmetic product containing it. Do not formulate into cosmetics.

โš ๏ธ
Concern Level: High

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Neomycin safe in cosmetics?

Neomycin is a potent contact allergen with cross-reactivity to other aminoglycosides, carries ototoxicity and nephrotoxicity risks with systemic absorption, contributes to antimicrobial resistance, and would trigger regulatory reclassification of any cosmetic product containing it. Do not formulate into cosmetics. The EU classifies Neomycin as "prohibited". Safety rating: POOR.

Is Neomycin allowed in the EU?

Neomycin EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Neomycin do in cosmetics?

Neomycin functions as: Antimicrobial. It is classified as a cosmetic ingredient in our database. CAS number: 1404-04-2 (base); 1405-10-3 (sulfate salt).

What is the Margin of Safety for Neomycin?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

๐Ÿ“ฑ

Is Neomycin in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Neomycin in your formulation.