CHAKRA AROMA RELAXING COLOR- capsicum oleoresin patch
mooni studio

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

CAPSICUM OLEORESIN

Inactive ingredients

Styrene isoprene rubber, silver powder, 1,2-hexandiol, 2hydroxy benzoic acid, glycerin, hydrogenated hydrocabon resin, aroma oil (patchouli oil, orange oil, lemon oil, eucalyptus oil, ylang-ylang oil, lavender oil, olibanum oil)

Purposes

Topical analgesic

Warnings

- It is normal that the product heats the attached area, but if a rash appears on the skin, stop using the product immediately and go to see a doctor.

- Those who have sensitive skin or dermatitis should avoid long-hour usage(over 5 hours).

- Be careful using the product before or after sauna and hot massage when your skin may be more sensitive than the usual.

- If you feel itchy, remove the patch immediately and wash off the area with cold water.

- Do NOT use the product during pregnancy.

- Do NOT use the product to infants/children under 30 months.

- This product is NOT a medicine, but one of the manufactured goods

For external use only

Keep out of reach of children.

Package label

CHAKRA AROMA RELAXING COLOR
capsicum oleoresin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72880-0100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY)	CAPSAICIN	0.2 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SILVER (UNII: 3M4G523W1G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72880-0100-1	7 in 1 PACKAGE	01/01/2019
1		36 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/01/2019

Labeler - mooni studio (694861053)

Name	Address	ID/FEI	Business Operations
Establishment
mooni studio		694861053	label(72880-0100) , manufacture(72880-0100) , pack(72880-0100)