CBDMEDIC ITCH AND RASH- allantoin, lidocaine hcl ointment 
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC

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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CBDMEDIC Itch and Rash 

Active Ingredients and Purpose

Allantoin 0.5% (Skin Protectant),
Lidocaine HCl 0.5% (External Analgesic)

Uses

For temporary relief and protection from itching associated with minor skin irritations and rashes.

Warnings

For external use only. Do not use on wounds or damaged skin. Avoid contact with eyes or mucous membranes. If symptoms persist for more than 7 days, discontinue use and consult a physician.

If pregnant or breast feeding, contact a physician prior to use.

Directions:

Adults and children 12 years of age and older: Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damaged
skin. Store at room temperature. Children under 12 years of age: ask a doctor.

Inactive ingredients

Beeswax (organic), cotton seed oil, hemp extract (THC-free), jojoba seed oil, palmarosa oil, peppermint oil, silver oxide, sorbic acid, stearic
acid (vegetable derived), tea tree oil, zinc oxide

PRINCIPAL DISPLAY PANEL

CBDMEDIC Itch Rash

CBDMEDIC ITCH AND RASH 
allantoin, lidocaine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-731
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
COTTONSEED OIL (UNII: H3E878020N)  
HEMP (UNII: TD1MUT01Q7)  
JOJOBA OIL (UNII: 724GKU717M)  
PALMAROSA OIL (UNII: 0J3G3O53ST)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SILVER OXIDE (UNII: 897WUN6G6T)  
SORBIC ACID (UNII: X045WJ989B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TEA TREE OIL (UNII: VIF565UC2G)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-731-401 in 1 CARTON03/06/2019
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/06/2019
Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC018950611manufacture(24909-731) , label(24909-731)

Revised: 3/2019
Document Id: e239e7d5-ac02-4031-932f-37c77a20b793
Set id: d22e5c71-ac31-4cc4-a453-877ed68868c3
Version: 1
Effective Time: 20190306
 
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC