Ambix First Aid

Dosage form: cream
Ingredients: DYCLONINE HYDROCHLORIDE 0.005g in 1g, PHENOL 0.005g in 1g
Labeler: Organics Corporation of America dba Ambix Laboratories
NDC Code: 10038-250

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.

Ambix First Aid Antiseptic & Pain Relieving Cream

Active Ingredients

Phenol 0.5%

Dyclonine Hydrochloride 0.5%

Purpose

First Aid Antiseptic

Topical Anesthetic

Uses

  • first aid to help protect against infection and for the temporary relief of pain and itching associated with minor burns, minor cuts, scrapes, insect bites, or minor skin irritations.

Warnings

■ For external use only ■ Do not bandage ■ Do not use in the eyes or apply over large areas of the body ■ Do not use longer than 1 week unless directed by a doctor

Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.

Ask a doctor before use if you have

a deep or puncture wound, an animal bite, serious burn, or before using on a child aged 2 or under.

Stop use and ask a doctor if

redness, irritation, swelling, or pain persists or increases.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Clean the affected area ■ Apply a small amount of this product on the area 1 to 3 times daily

Other Information

  • Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF).
  • You may report serious side effects to the phone number provided under “Questions?” below

Inactive Ingredients

Allantoin, Benzyl Alcohol, Disodium EDTA, Glyceryl Stearate, Mineral Oil, Methyl Paraben, Petrolatum, Propyl Paraben, Sodium Lauryl Sulfate, Stearic Acid, Stearyl Alcohol, Triethanolamine, Water


Ambix

FIRST AID

Antiseptic & Pain Relieving Cream

Net Wt. 7/8 oz. (25 grams)

Dist. by Ambix Laboratories, Totowa, NJ 07512 ■ Made in USA ■ © 2013

Ambix

FIRST AID

Antiseptic & Pain Relieving Cream

Net Wt. 1-1/2 oz. (42.5 grams)

Dist. by Ambix Laboratories, Totowa, NJ 07512 ■ Made in USA ■ © 2013

AMBIX FIRST AID 
dyclonine hydrochloride and phenol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10038-250
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DYCLONINE HYDROCHLORIDE (DYCLONINE) DYCLONINE HYDROCHLORIDE0.005 g  in 1 g
PHENOL (PHENOL) PHENOL0.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
BENZYL ALCOHOL 
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
METHYLPARABEN 
PETROLATUM 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
STEARIC ACID 
STEARYL ALCOHOL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:10038-250-251 TUBE in 1 BOX
125 g in 1 TUBE
2NDC:10038-250-421 TUBE in 1 BOX
242.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/22/2013
Labeler - Organics Corporation of America dba Ambix Laboratories (061061164)
Registrant - Organics Corporation of America dba Ambix Laboratories (061061164)
Establishment
NameAddressID/FEIOperations
Suite K Value Added Services LLC036822144manufacture(10038-250)

Revised: 08/2013
 
Organics Corporation of America dba Ambix Laboratories

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.

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