SNAP CRACK NATURAL PAIN RELIEVING GEL- menthol camphor gel 
Sombra Cosmetics INC

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.

----------

Snap Crack Natural Pain relieving Gel

Active Ingredients

Menthol USP 3%, Camphor USP 3%

Purpose

Purpose
External Analgesic

Keep out of reach of children

Keep out of reach of children

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

Aloe Baradensis Leaf Juice, Camillia Sinensis (Green Tea) Leaf Extract, Caprylyl Glycol, Capsicum Annuum Fruit Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Glycerin, Hamamelis Viginiana (Witch Hazel) Leaf Extract, Phenoxyethanol, Purified Water, Rose Damascena Flower Water, Sodium Carbonate, Filipendula Ulmaris (Queen of the Prairie) Flower Extract, Yucca Schidigera Root Extract.

Questions or Comments

1-800-225-3963

Label

SNAP CRACK NATURAL PAIN RELIEVING GEL 
menthol camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-5310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.03 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC).03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
WATER (UNII: 059QF0KO0R)  
CAPSAICIN (UNII: S07O44R1ZM)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITCH HAZEL (UNII: 101I4J0U34)  
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
ORANGE PEEL (UNII: TI9T76XD44)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-5310-1113.4 g in 1 JAR; Type 0: Not a Combination Product12/28/2021
2NDC:61577-5310-23544 g in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/28/2021
Labeler - Sombra Cosmetics INC (097464309)
Establishment
NameAddressID/FEIBusiness Operations
Sombra Cosmetic INC097464309manufacture(61577-5310) , label(61577-5310)

Revised: 12/2021
Document Id: 9bac8f27-53c1-43f6-951e-5fae62fc2447
Set id: 287a3b7d-9134-4368-bf8f-32eaa31dd660
Version: 1
Effective Time: 20211228
 
Sombra Cosmetics INC