TEEVODAR- allantoin cream
PEER PHARM LTD.

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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Active Ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts scrapes burns

Warnings

For external use only
When using this product do not get into eyes
Stop use and ask a doctor if
contition worsens
symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.
Children under 12 years of age: consult a doctor

Inactive Ingredients

Ceteareth-20, Cetearyl alcohol, Cetyl alcohol, ethylhexylglycerin, Hamamelis virginiana (witch hazel) leaf extract, Isopropyl myristate, Lanolin, Mineral oil, Origanum vulgare (oregano) leaf extract, Petrolatum, Phenoxyethanol, Purified water, Rosmarinus officinalis (rosemary) leaf extract, Zea mayes (corn) oil

Product label

image description

TEEVODAR
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69435-1301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
OREGANO (UNII: 0E5AT8T16U)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ROSEMARY (UNII: IJ67X351P9)
CORN OIL (UNII: 8470G57WFM)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69435-1301-1	1 in 1 CARTON	05/15/2023
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/15/2023

Labeler - PEER PHARM LTD. (514678390)

Registrant - PEER PHARM LTD. (514678390)