HAND AND WRIST PAIN CREAM- histamine dihydrochloride cream 
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.

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Hand and Wrist Pain Cream

Active Ingredients

Histamine Dihydrochloride 0.025%

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

PURPOSE

PURPOSE

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises

Warnings

For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this product. When using this product: avoid contact with eyes.  If product gets into eyes, rinse thoroughly with water.  Do not bandage tightly or use a heating pad.

Stop use and ask doctor if: rash appears.  Condition worsens. If symptoms persist for more than 7 days or if symptoms clear up and occur again within a few days.

If pregnant or breast feeding, ask a health professional before use.

Directions

​For Use by Adults and Children over 12 years.  ​Apply a thin layer to pain site and massage until thoroughly absorbed into skin.  Apply no more than 3 to 4 times daily.

Children 12 years or younger consult a physician

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Butylene Glycol, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Purica Granatum (Pomegranate) Extract, Saccharide Isomerate, Sodium Polyacrylate, Tochopheryl Acetate (Vitamin E), Trideceth-6, Vaccinium Angustifolium (Blueberry) Fruit Extract, Zemea (Corn) Propanediol

Questions or Comments?

Call 1-888-600-4642

Label

LABEL

HAND AND WRIST PAIN CREAM 
histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-8122
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE.00025 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Water (UNII: 059QF0KO0R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PUNICA GRANATUM SEED (UNII: 7294Z34NS7)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61577-8122-4119 g in 1 TUBE; Type 0: Not a Combination Product12/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/09/2019
Labeler - Sombra Cosmetics, Inc. (097464309)
Establishment
NameAddressID/FEIBusiness Operations
Sombra Cosmetics, Inc.097464309manufacture(61577-8122) , label(61577-8122)

Revised: 12/2019
Document Id: a83699af-6473-4a9a-a893-a3070783d2c7
Set id: 49b35ba4-ecb0-4016-94b8-5351fbda8c26
Version: 1
Effective Time: 20191209
 
Sombra Cosmetics, Inc.