GUNA-DERMO- aldesleukin - arsenic trioxide - atropa belladonna - canakinumab - echinacea angustifolia - graphite - melatonin - plantago major - solanum dulcamara flower - sulfur - solution/ drops
Guna spa

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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GUNA-DERMO

ACTIVE INGREDIENTS/PURPOSE

ARSENICUM ALBUM       6C   SKIN BLISTERS
BELLADONNA       6C   SWELLING
DULCAMARA       6C   MUSCLE SORENESS
ECHINACEA ANGUSTIFOLIA   6C   ANTI-INFECTION
GRAPHITES       6C   SKIN INFLAMMATION
INTERLEUKIN 1 BETA   7C   IMMUNE STRENGTHENING
INTERLEUKIN 2       4C   IMMUNE STRENGTHENING
MELATONIN       4C   HORMONAL SUPPORT
PLANTAGO MAJOR       4C   DETOXIFICATION
SULPHUR           6C   SENSITIVE SKIN

USES

Temporary relief of symptoms of general skin irritation and rashes such as:

Itching
Dryness
Hypersensitivity

WARNINGS

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 30%

PREGNANCY

If pregnant or breast-feeding ask a doctor before use

WARNINGS

Keep this and all medicines out of reach of children

DIRECTIONS

Adults and children 12 years and older 20 drops in a little water, 2 times per day

Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day

Children under 6 years 5 drops in a glass of water, 2 times per day

QUESTIONS

Questions?: info@gunainc.com, tel. (484) 223-3500

Take 15 minutes before meals

Inactive ingredient. Ethyl alcohol 30%.

PRINCIPAL DISPLAY PANEL

5USDER-Rev02-21-05-18

GUNA-DERMO
aldesleukin - arsenic trioxide - atropa belladonna - canakinumab - echinacea angustifolia - graphite - melatonin - plantago major - solanum dulcamara flower - sulfur - solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-295
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALDESLEUKIN (UNII: M89N0Q7EQR) (ALDESLEUKIN - UNII:M89N0Q7EQR)	ALDESLEUKIN	4 [hp_C] in 30 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_C] in 30 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_C] in 30 mL
CANAKINUMAB (UNII: 37CQ2C7X93) (CANAKINUMAB - UNII:37CQ2C7X93)	CANAKINUMAB	7 [hp_C] in 30 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	6 [hp_C] in 30 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	6 [hp_C] in 30 mL
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	4 [hp_C] in 30 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	4 [hp_C] in 30 mL
SOLANUM DULCAMARA FLOWER (UNII: W6J1279A6K) (SOLANUM DULCAMARA FLOWER - UNII:W6J1279A6K)	SOLANUM DULCAMARA FLOWER	6 [hp_C] in 30 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_C] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)	9 mL in 30 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17089-295-18	1 in 1 BOX	12/21/2018
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/23/2006

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-295)