TERRASILMED BURN CARE- allantoin,menthol ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Aidance Skincare & Topical Solutions, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Allantoin 0.5%                                       Skin Protectant Menthol 0.15%                                      Topical Analgesic Helps protect skin and provide temporary relief of pain and itching due to minor burns, sunburn, and skin irritations.

Authorization status:

OTC monograph not final

Summary of Product characteristics

TERRASILMED BURN CARE- 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._
----------
DRUG FACTS
ACTIVE INGREDIENTS PURPOSE
Allantoin 0.5% Skin Protectant
Menthol 0.15% Topical Analgesic
_USES_
Helps protect skin and provide temporary relief of pain and itching
due to minor burns,
sunburn, and skin irritations.
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT, do not get into eyes. Do not apply to open
wounds or
damaged skin. If symptoms persist for more than seven days discontinue
use and
consult physician.
IF PREGNANT OR BREASTFEEDING, contact physician prior to use.
KEEP OUT OF REACH OF CHILDREN. If swallowed, consult a physician.
_DIRECTIONS_
Apply directly to affected area. Do not use more than 4 times per day.
Do not bandage
damaged skin. Store at room temperature. May stain fabrics.
_INACTIVE INGREDIENTS_
Beeswax, MCT (coconut oil), Petrolatum, Silver Stearate, Sorbic Acid
QUESTIONS?
401-432-7750 or www.aidance.com
PRODUCT LABEL
TERRASILMED BURN CARE
allantoin,menthol ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:24909-027
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Aidance Skincare & Topical Solutions, LLC
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)
ALLANTOIN
0.5 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
0.15 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
PETROLATUM (UNII: 4T6H12BN9U)
SILVER STEARATE (UNII: 4H6PCL92ZN)
SORBIC ACID (UNII: X045WJ989B)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:24909-027-
50
50 g in 1 TUBE; Type 0: Not a Combination
Product
05/08/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NU