Pain relieving lotion

Directions

Adults and children 2 years and older:
Massage a small amount of lotion directly on the skin over the affected area. Repeat as necessary but do not apply more than 4 times daily.
Children under 2 years of age: Consult a Physician

Active ingredient

Menthol USP 3.85%
Camphor USP 3.85%
Capsaicin USP 0.0355%

Inactive ingredients

Aloe Vera, Arnica Extract, Boswellia Serrata Extract, Green Tea Extract, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Orange Fruit Extract, Grapefruit Extract, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis Leaf Extract, Phenoxyethanol, Purified Water, Rose Extract, Vitamin E, Triethanolamine, Yucca Extract

Other information

Store in a cool dry place with lid or cap closed tightly.
Flammable: Keep away from excessive heat or open flame

Keep out of reach of children

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Purpose

Pain Reliever

Uses

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

Dosage & administration section

Warnings

For external use only

When using this product:

Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water

Stop use and ask a doctor if:

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritatio develops

If pregnant or breast feeding:

Ask a health professional before use

This product contains capsaicin

and may cause temporary burning, stinging, inflammation, redness or welts on the application site thatususally disappear in a few days. If you experience any of these symptoms discontinue use and contact your doctor immediately

Ingredients and appearance - Product information

Pain relieving lotion- Menthol, camphor, capsaicin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68678-039
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 3.85 gin 100 mL
Camphor (synthetic) ( UNII: 5TJD82A1ET)( Camphor (synthetic) - UNII: 5TJD82A1ET ) 3.85 gin 100 mL
Capsaicin ( UNII: S07O44R1ZM)( Capsaicin - UNII: S07O44R1ZM ) 0.0355 gin 100 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Aloe vera leaf ( UNII: ZY81Z83H0X)
Arnica montana ( UNII: O80TY208ZW)
Boswellia serrata whole ( UNII: X7B7P649WQ)
Green tea leaf ( UNII: W2ZU1RY8B0)
Carbomer 940 ( UNII: 4Q93RCW27E)
Cetostearyl alcohol ( UNII: 2DMT128M1S)
Cetearyl glucoside ( UNII: 09FUA47KNA)
Citrus aurantium fruit ( UNII: DQD16J2B5O)
Grapefruit ( UNII: O82C39RR8C)
Dimethyl sulfone ( UNII: 9H4PO4Z4FT)
Ethylhexylglycerin ( UNII: 147D247K3P)
Glycerin ( UNII: PDC6A3C0OX)
Ilex paraguariensis leaf ( UNII: 1Q953B4O4F)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Rosa canina flower ( UNII: 81MCR2UQ6Q)
.alpha.-tocopherol acetate, dl- ( UNII: WR1WPI7EW8)
Trolamine ( UNII: 9O3K93S3TK)
Yucca schidigera ( UNII: 08A0YG3VIC)

Product Characteristics

Color white

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - AHC VENTURES CORP DBA CRY( 131871779)

Establishment

Name ID/FEI Business Operations
AHC VENTURES CORP DBA CRY 131871779 manufacture( 68678-039)

Package label.principal display panel

CryoDerm
HEAT
PAIN RELIEVING
WARMING LOTION
with
Menthol . Camphor . Capsaicin
And Essential Oils & Natural Extracts
Paraben Free / Propylene Glycol Free / Aspirin Free
NSAID Free / Silicone Dioxide Free / Gluten Free
Fast, Deep Penetrating Pain Relief for:
Muscle Strains, Joint Pain, Backache, Arthritis,
Sprained Ligaments & Bruises
Pain Relieving Lotion . Greaseless . No-Mess . Non-Staining
16 fl.oz. 449mL