DailyMed - SOMBRA WARM THERAPY- menthol camphor gel

NDC Code(s): 61577-3216-1, 61577-3216-2, 61577-3216-3, 61577-3216-4, view more
61577-3216-5, 61577-3216-6, 61577-3216-7, 61577-3216-9
Packager: SOMBRA COSMETICS INC.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated May 27, 2025

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Active Ingredients
Menthol USP 3%, Camphor USP 3%

Menthol USP 3%, Camphor USP 3%
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Purpose
Purpose - External Analgesic

Purpose
External Analgesic
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Keep out of reach of children
Keep out of reach of children

Keep out of reach of children
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Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

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

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.

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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 ...

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.

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Inactive Ingredients
aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil ...

aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, capsicum annuum fruit extract
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Questions or Comments
1-800-225-3963

1-800-225-3963

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

SOMBRA WARM THERAPY menthol camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61577-3216
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61577-3216-1	3628.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/14/2016
2	NDC:61577-3216-2	907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/14/2016
3	NDC:61577-3216-3	226.8 g in 1 JAR; Type 0: Not a Combination Product	06/14/2016
4	NDC:61577-3216-4	113.4 g in 1 JAR; Type 0: Not a Combination Product	06/14/2016
5	NDC:61577-3216-5	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/14/2016
6	NDC:61577-3216-6	113.4 g in 1 TUBE; Type 0: Not a Combination Product	06/14/2016
7	NDC:61577-3216-7	56.7 g in 1 JAR; Type 0: Not a Combination Product	06/14/2016
8	NDC:61577-3216-9	5 g in 1 POUCH; Type 0: Not a Combination Product	06/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	06/13/2016

Labeler - SOMBRA COSMETICS INC. (097464309)

Name	Address	ID/FEI	Business Operations
Establishment
SOMBRA COSMETICS INC.		097464309	manufacture(61577-3216) , label(61577-3216)

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Published Date (What is this?)	Version	Files
May 29, 2025	8 (current)	download
May 26, 2022	7	download
Mar 6, 2020	6	download
Jul 12, 2016	5	download
Jan 18, 2012	4	download

Published Date (What is this?)

Version

Files

May 29, 2025

8 (current)

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May 26, 2022

download

Mar 6, 2020

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Jul 12, 2016

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Jan 18, 2012

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	RxCUI	RxNorm NAME	RxTTY
1	630714	camphor 3 % / menthol 3 % Topical Gel	PSN
2	630714	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel	SCD
3	630714	camphor 3 % / menthol 3 % Topical Gel	SY
4	1090954	SOMBRA Warm Therapy 3 % / 3 % Topical Gel	PSN
5	1090954	camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel [SOMBRA Warm Pain Relieving Gel]	SBD
6	1090954	SOMBRA Warm Pain Relieving Gel (camphor 3 % / menthol 3 % ) Topical Gel	SY

Label: SOMBRA WARM THERAPY- menthol camphor gel

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	NDC
1	61577-3216-1
2	61577-3216-2
3	61577-3216-3
4	61577-3216-4
5	61577-3216-5
6	61577-3216-6
7	61577-3216-7
8	61577-3216-9

Label: SOMBRA WARM THERAPY- menthol camphor gel

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SOMBRA WARM THERAPY- menthol camphor gel

Number of versions: 5

SOMBRA WARM THERAPY- menthol camphor gel

SOMBRA WARM THERAPY- menthol camphor gel

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SOMBRA WARM THERAPY- menthol camphor gel

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.