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Medically reviewed on October 9, 2017

Dosage form: liquid
Ingredients: Pramoxine Hydrochloride 1g in 100mL
Labeler: S.S.S. Company
NDC Code: 12258-223

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.


Active Ingredient:

Pramoxine Hydrochloride 1%


Local Anesthetic


For the temporary relief of pain and itching associated with fever blisters and cold sores


For external use only

When using this product
  • Do not swallow
  • Avoid contact with the eyes
  • Avoid contact with the nose

Stop use and consult a doctor If

  • Redness
  • Swelling
  • Irritation or pain persists or increases, condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Keep out of the reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily; avoid moistening area for 2 to 3 minutes following application. Children under 2 years of age: consult a doctor.

Other Information
  • Keep away from heat, sparks, and open flame
  • Store in a cool place
  • Keep lid tightly capped.
  • To report an adverse event or obtain product information contact (404) 521-0857.

Inactive Ingredients

ethyl alcohol and ethyl ether

Principal Display Panel

NDC 12258-223-05


Pain Relieving Anesthetic for

Fever Blisters • Cold Sores

Contains Ether

0.5 FL OZ (15mL)

Important: Begin application at the

first sign of a fever blister or cold




for Relieving Pain & Itching of

Fever Blisters & Cold Sores



Other Packaging Content

Manufactured by S.S.S. Company, Atlanta, GA 30315, USA

Rev. E

pramoxine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12258-223
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:12258-223-051 BOTTLE in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/31/1995
Labeler - S.S.S. Company (003288321)
S.S.S. Company003288321MANUFACTURE(12258-223), PACK(12258-223), LABEL(12258-223)

S.S.S. Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.