CBDMEDIC ITCH AND RASH- allantoin, lidocaine hcl ointment

CBDMEDIC Itch and Rash by

Drug Labeling and Warnings

CBDMEDIC Itch and Rash by is a Otc medication manufactured, distributed, or labeled by AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

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

INGREDIENTS AND APPEARANCE

CBDMEDIC ITCH AND RASH 
allantoin, lidocaine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-731
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-731-40	1 in 1 CARTON	03/06/2019
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/06/2019

Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC		018950611	manufacture(24909-731) , label(24909-731)