Green Idea-Herbamedicus Sundermia

Aldamed by

Drug Labeling and Warnings

Aldamed by is a Otc medication manufactured, distributed, or labeled by Herbamedicus, s.r.o., Green Idea s.r.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALDAMED- sundermia sun-exposure skin relief gel gel 
Herbamedicus, s.r.o.

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Green Idea-Herbamedicus Sundermia

Active ingredient

Menthol 3%.....................Topical Analgesic

Topical Analgesic

Use

Temporary relief of pain from sunburn, minor burns, bruises, and scrapes.

warnings

For external use only. Keep away from heat or flame.

Do not use

directly on mucous membranes

on open skin wounds or burns

When using this product

do not use it in or near the eyes or mouth.

if pregnant or if you have a cough associated with smoking, excessive phlegm, asthma, emphysema, or persistent or chronic cough.

Stop use and ask a doctor

if irritation, itching, or rash occurs.

Keep out of reach of children

If swallowed, get medical help, or contact a poison control center immediately at 1-800-222-1222.

Directions

apply on the affected area and rub gently till absorbed. Apply up to 3 times daily.

do no use on children below the age of 3 years old

Other information

Store in a cool, and dry place and avoid freezing and excessive heat

Do not expose the product to the direct sunlight

Inactive ingredient

Aqua, glycerin, biosacharide gum-1, polysorbate 80, prunus amygdalus dulcis oil, carbomer, phenoxyethanol, ethylhexylglycerin, panthenol, hippophae rhamnoides fruit extract, rosmarinus officinalis leaf extract, simmondsia chinensis seed oil, calendula officinalis flower extract, menthol 0,3%, beta-glucan, sodium hydroxide, rosa canina fruit oil, aloe barbadensis leaf juice, tocopheryl acetate, persea gratissima oil, hydrogenated palm glycerides, butyrospermum parkii butter, lavandula officinalis flower extract, arnica montana flower extract, hypericum perforatum extract, melissa officinalis flower/leaf/stem extract, camellia sinensis flower extract, centella asiatica extract, vaccinium myrtillus fruit extract, vitis vinifera seed oil, chamomilla recutita flower extract, hamamelis virginiana leaf extract, macadamia ternifolia seed oil, babassu oil glycereth-8 esters, prunus armeniaca kernel oil, D&C orange no 4.

200 mL NDC: 82811-114-11

ALDAMED 
sundermia sun-exposure skin relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82811-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
AVOCADO OIL (UNII: 6VNO72PFC1)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CHAMOMILE (UNII: FGL3685T2X)
SHEA BUTTER (UNII: K49155WL9Y)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
MACADAMIA OIL (UNII: 515610SU8C)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BABASSU OIL GLYCERETH-8 ESTERS (UNII: 12XQ76K0YL)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
ROSEMARY OIL (UNII: 8LGU7VM393)
BILBERRY (UNII: 9P2U39H18W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
GLYCERIN (UNII: PDC6A3C0OX)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82811-114-11	200 mL in 1 TUBE; Type 0: Not a Combination Product	09/06/2022	12/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/06/2022	12/31/2023

Labeler - Herbamedicus, s.r.o. (495275964)

Establishment
Name	Address	ID/FEI	Business Operations
Green Idea s.r.o.		361646523	manufacture(82811-114)

Revised: 7/2024

Document Id: 1e0eaf8e-06ba-e95e-e063-6294a90a6682

34390-5

Set id: e806bd17-59c5-524a-e053-2a95a90aca9f

Version: 3

Effective Time: 20240725