soothing Psoriasis relief lotion

Soothing psoriasis relief by

Drug Labeling and Warnings

Soothing psoriasis relief by is a Homeopathic medication manufactured, distributed, or labeled by Carolina Cannabis Creations L.L.C. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOOTHING PSORIASIS RELIEF- psoriasis relief lotion 
Carolina Cannabis Creations L.L.C

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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soothing Psoriasis relief lotion

active ingredients

arnica montana 3.58%

Eucalyptus globulus oil <1%

salicylic acid 1.8%

purpose

Topical analgesic

Skin protectant

Psoriasis

Uses

Temporary relief of skin irritation, itching redness and flaking associated with, eczema, psoriasis, seborrheic dermatitis, bug bites.

Warnings

For external use only

when using this product

avoid contact with eyes, avoid using on deep wounds, if you are allergic to any of the listed ingredients

Stop use and ask doctor if

condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days.

stop using and ask doctor if

condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days.

If pregnant or breast feeding

consult a health professional before use.

in case of overdose

seek medical help or contact a poison control center right away

Directions

Adults and children 12 years and over; apply to affected area one to four times daily.

children under 12 years; consult a doctor

keep out of reach of children

keep out of reach of children

other information

store at 68-77 degrees F (20-20 degrees C), avoid direct sunlight

inactive ingredients

water(aqua), vitellaria paradoxa (shea) butter, cera alba (beeswax), oryza sativa (rice bran) oil, prunus dolcis (sweet almond) oil, simmondsia chinensis (jojoba) oil, cannabidiol, cannabis sativa (hemp seed) oil, maranta arundinacea (arrowroot) powder, benzyl alcohol, bonzoic acid, dehydroacetic acid, cymbopogon citratus (lemon grass) oil, melaleuca alternifolia (tea tree) oil.

4oz lotion label

SOOTHING PSORIASIS RELIEF 
psoriasis relief lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) (ARNICA MONTANA FLOWER WATER - UNII:U7L2JP51PR)	ARNICA MONTANA FLOWER WATER	4.01 g  in 118.1 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.29 g  in 118.1 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3.07 g  in 118.1 g

Inactive Ingredients
Ingredient Name	Strength
RICE BRAN OIL (UNII: LZO6K1506A)	4.08 g  in 118.1 g
DEHYDROACETIC ACID (UNII: 2KAG279R6R)	0.08 g  in 118.1 g
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	1.37 g  in 118.1 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	5.68 g  in 118.1 g
TEA TREE OIL (UNII: VIF565UC2G)	0.32 g  in 118.1 g
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)	0.28 g  in 118.1 g
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)	0.86 g  in 118.1 g
CANNABIDIOL (UNII: 19GBJ60SN5)	1.13 g  in 118.1 g
WATER (UNII: 059QF0KO0R)	80.79 g  in 118.1 g
SHEA BUTTER (UNII: K49155WL9Y)	10.76 g  in 118.1 g
JOJOBA OIL (UNII: 724GKU717M)	1.52 g  in 118.1 g
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.16 g  in 118.1 g
ALMOND OIL (UNII: 66YXD4DKO9)	2.72 g  in 118.1 g
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.98 g  in 118.1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-413-34	118.1 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/13/2022	08/17/2023

Labeler - Carolina Cannabis Creations L.L.C (118697474)

Establishment
Name	Address	ID/FEI	Business Operations
Carolina Cannabis Creations L.L.C		118697474	manufacture(82876-413)

Revised: 8/2023

Document Id: 0318282b-6ee2-ffb4-e063-6394a90afc8f

34390-5

Set id: e8970b07-a85c-9a9b-e053-2a95a90abca5

Version: 2

Effective Time: 20230817