TERRASIL ITCH, RASH AND PAIN RELIEF- allantoin, menthol ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Allantoin 0.5%, Menthol 0.15%

Available from:

Aidance Skincare & Topical Solutions, LLC

Prescription type:

OTC DRUG

Therapeutic indications:

Allantoin - Skin Protectant Menthol - Topical Anesthetic For temporary protection and relief of pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.

Authorization status:

OTC monograph final

Summary of Product characteristics

TERRASIL ITCH, RASH AND PAIN RELIEF- ALLANTOIN, MENTHOL OINTMENT
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC
_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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DRUG FACTS
ACTIVE INGREDIENTS
Allantoin 0.5%, Menthol 0.15%
PURPOS E
Allantoin - Skin Protectant
Menthol - Topical Anesthetic
US ES
For temporary protection and relief of pain and itching associated
with minor skin irritations, rashes,
eczema and/or insect bites.
WARNINGS
FOR EXTERNAL USE ONLY. Avoid contact with eyes. Do not apply to open
wounds
or damaged skin. If symptoms persist for more than seven days,
discontinue use and
consult physician. If swallowed, consult physician. Do not bandage
tightly.
IF PREGNANT OR BREAST FEEDING, contact physician prior to use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, consult physician.
DIRECTIONS
Apply directly to effected area. Do not use more than four
times per day. Store at room temperature.
INACTIVE INGREDIENTS
bentonite, cera alba (organic beeswax), cotton seed oil, eucalyptus
citriodora oil, magnesium oxide,
peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil,
zinc oxide.
PRINCIPAL DISPLAY PANEL - 44G LABEL
Aidance Skincare & Topical Solutions, LLC
TERRASIL ITCH, RASH AND PAIN RELIEF
allantoin, menthol ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:249 0 9 -154
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALLA NTO IN (UNII: 344S277G0 Z) (Allanto in - UNII:344S277G0 Z)
Alla nto in
0 .5 g in 10 0 g
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
0 .15 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BENTO NITE (UNII: A3N5ZCN45C)
CO TTO NSEED O IL (UNII: H3E8 78 0 20 N)
EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)
JO JO BA O IL (UNII: 724GKU717M)
MAGNESIUM O XIDE (UNII: 3A3U0 GI71G)
PEPPERMINT O IL (UNII: AV0 9