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Swiftalyn Numbing Cream

Approved
Approval ID

3f74c4a6-26f0-ddf7-e063-6394a90a1225

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

GENUINE INNOVATION LTD

DUNS: 226088244

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine 4%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code87013-002
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine 4%
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (15)

MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN LECITHINInactive
Code: 1DI56QDM62
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ALOE VERA LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
LIDOCAINEActive
Quantity: 4 g in 100 g
Code: 98PI200987
Classification: ACTIB
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

2321

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

For use as a local anesthetic to numb the skin prior to minor medical or cosmetic procedures

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Lidocaine 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/5/2025

For temporary relief of minor pain, burning and soreness.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/23/2025

■ Adults: When practical, clean and dry the affected area. Apply externally to the affected area up to 3 times daily. ■ Children under 12 years of age: consult a doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/23/2025

■ Store at room temperature 15–30°C (59–86°F) ■ Keep away from direct sunlight or heat

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/23/2025

Email at:

service@swiftalyn.co.uk

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2025

For external use only

■ avoid contact with eyes or mucous membranes ■ Use only as directed ■ do not put this product into the rectum by using fingers or any mechanical device or applicator

■ condition worsens or does not improve within 7 days ■ rectal bleeding occurs ■ allergic reaction occurs to ingredients in this product ■ symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2025

Purified Water, Propylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Lecithin, Polysorbate 80, Aloe Vera Leaf Juice, Carbomer, Triethanolamine, Tocopheryl Acetate, Allantoin, Menthol, Phenoxyethanol, Ethylhexylglycerin.

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Swiftalyn Numbing Cream - FDA Drug Approval Details