PAIN NO MORE THERAPY: Package Insert and Label Information

PAIN NO MORE THERAPY- menthol and camphor (synthetic) 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.

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 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, propagermanium oil (germanium oil), caprylyl glycol, capsicum annuum fruit extract

Questions or Comments

1-800-225-3963

LABEL
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PAIN NO MORE THERAPY
menthol camphor gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61577-7365
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.03 g in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.03 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CARBOMER HOMOPOLYMER TYPE C
DECYL GLUCOSIDE
WATER
CAPSAICIN
GRAPEFRUIT SEED OIL
GREEN TEA LEAF
FILIPENDULA ULMARIA FLOWER
ROSA CENTIFOLIA FLOWER OIL
SODIUM CARBONATE
GLYCERIN
WITCH HAZEL
YUCCA SCHIDIGERA ROOT
ORANGE PEEL
PHENOXYETHANOL
CAPRYLYL GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61577-7365-4 113.4 g in 1 JAR None
2 NDC:61577-7365-5 113.4 g in 1 TUBE None
3 NDC:61577-7365-1 5 g in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/13/2018
Labeler — SOMBRA COSMETICS INC. (097464309)
Establishment
Name Address ID/FEI Operations
SOMBRA COSMETICS INC. 097464309 manufacture (61577-7365), label (61577-7365)

Revised: 03/2020 SOMBRA COSMETICS INC.

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