INSECT BITE RELIEF 01- menthol spray 
Cosmuses Cosmetics (Ningbo) Co., Ltd.

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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insect bites relief spray

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

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

Stop use and ask a doctor if

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

Directions

Other information

Protect from excessive heat (40 oC/ 104 oF)

Inactive ingredients

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

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.

82953-011

INSECT BITE RELIEF  01
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
BORNEOL (UNII: M89NIB437X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82953-011-0330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2022
2NDC:82953-011-0220 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2022
3NDC:82953-011-0110 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01609/30/2022
Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
Establishment
NameAddressID/FEIBusiness Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-011)

Revised: 7/2023
Document Id: 006e4103-36dd-7405-e063-6394a90aa09e
Set id: 006e457d-bfcd-791a-e063-6294a90a8d66
Version: 1
Effective Time: 20230714
 
Cosmuses Cosmetics (Ningbo) Co., Ltd.