ALLANTOIN- medicinal massage oil oil 
Carolina Cannabis Creations L.L.C

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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Medicinal Massage Oil

Active ingredients

Allantoin......1%

Purpose

Skin protectant

Uses

Helps prevent and temporarily protect and help relieve chafed, chapped, or cracked skin.

Helps prevent and protect from the drying of wind and cold weather

Warnings

For external use only.

Do not use

on deep or puncture wounds, animal bites, serious burns

When using this product

Do not get into eyes

Stop use and ask doctor if

condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days, rash or irritation occurs

Stop use and ask doctor if

Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs

If pregnant or breast feeding

Consult a health professional before use.

in case of overdose

seek medical help or contact a poison control center right away

Directions

shake well before use.

adults and children 2 years and over; apply as needed.

children under 2 years; consult a doctor

keep out of reach of children

Keep out of reach of children

Other information

Store at 68-77 degrees F (20-25 degrees C), avoid direct sunlight

inactive ingredients

Arnica montana, Cannabidiol, Jojoba oil, Lavender oil, Peppermint oil, Rice bran oil, Sweet almond oil.

bottle label

ALLANTOIN 
medicinal massage oil oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82876-438
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 108.48 g
Inactive Ingredients
Ingredient NameStrength
RICE BRAN OIL (UNII: LZO6K1506A) 65.29 g  in 108.48 g
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.28 g  in 108.48 g
PEPPERMINT OIL (UNII: AV092KU4JH) 0.15 g  in 108.48 g
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 2.85 g  in 108.48 g
ALMOND OIL (UNII: 66YXD4DKO9) 27.2 g  in 108.48 g
JOJOBA OIL (UNII: 724GKU717M) 10.58 g  in 108.48 g
CANNABIDIOL (UNII: 19GBJ60SN5) 1.13 g  in 108.48 g
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82876-438-34108.48 g in 1 BOTTLE; Type 0: Not a Combination Product09/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01609/06/2022
Labeler - Carolina Cannabis Creations L.L.C (118697474)
Establishment
NameAddressID/FEIBusiness Operations
Carolina Cannabis Creations L.L.C118697474manufacture(82876-438)

Revised: 9/2023
Document Id: 04b54195-468d-33ab-e063-6294a90acd13
Set id: 04b5619b-2122-f159-e063-6394a90a2e05
Version: 1
Effective Time: 20230906
 
Carolina Cannabis Creations L.L.C