AMBIX FIRST AID- dyclonine hydrochloride and phenol cream 
Organics Corporation of America dba Ambix Laboratories

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.

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Ambix First Aid Antiseptic & Pain Relieving Cream

Active Ingredients

Phenol 0.5%

Dyclonine Hydrochloride 0.5%

Purpose

First Aid Antiseptic

Topical Anesthetic

Uses

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

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

First Aid Cream, 25g

First Aid Cream, 42.5g

AMBIX FIRST AID 
dyclonine hydrochloride and phenol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10038-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O) DYCLONINE HYDROCHLORIDE0.005 g  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10038-250-251 in 1 BOX08/22/2013
125 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10038-250-421 in 1 BOX08/22/2013
242.5 g in 1 TUBE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Suite K Value Added Services LLC036822144manufacture(10038-250)

Revised: 11/2019
Document Id: 9689b2a7-6fce-5b51-e053-2a95a90ae583
Set id: 575989be-b9f2-4778-a92d-4ec8e1325c45
Version: 3
Effective Time: 20191104
 
Organics Corporation of America dba Ambix Laboratories