INSECT BITE RELIEF 01- menthol spray

insect bite relief by

Drug Labeling and Warnings

insect bite relief by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 1%

Purpose

Anti-itch

Insect bite relief spray

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema, psoriasis, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis and more.

Warnings

For external use only.

Do not use

• in or near the eyes
• for disper rash; ask a doctor

WHEN USING

Ask a doctor before use if you are using any other hydrocortisone product.

STOP USE

Stop use and ask a doctor if

• condition worsens or if symptoms persist for more than 7 days
• symptoms last more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years, do not use; ask a doctor.

Other information

Protect from excessive heat (40 oC/ 104 oF)

Inactive ingredients

Alcohol, Aqua, Menthyl Lactate, Borneol, Butylene Glycol, Glycerin

INDICATIONS & USAGE

Do not begin use of any hydrocortisone product unless you've asked a doctor. Do not use in the genital area if you have a vaginal discharge. Consult a doctor. Do not use more than directed unless told to do so by a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSECT BITE RELIEF  01
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
BORNEOL (UNII: M89NIB437X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-011-03	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2022
2	NDC: 82953-011-02	20 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2022
3	NDC: 82953-011-01	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	09/30/2022

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-011)